Angioplasty balloons

Pacific Xtreme

by Medtronic, Inc.

A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

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Where to buy Pacific Xtreme

Contact Medtronic, Inc. directly; they can quote, ship, or point you to the distributor for your country.

From medtronic.com, checked October 2026.

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Pacific Xtreme models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
PCU040150090Length 150.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040150090Length 150.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040150090β€” Not statedAvailable
PCU040150090Length 150.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040150130Length 150.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040150130β€” Not statedAvailable
PCU040150130Length 150.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040150130Length 150.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040200090β€” Not statedAvailable
PCU040200090Length 200.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040200090Outer Diameter 4.0 mm; Length 200.0 mm Not statedAvailable
PCU040200130Outer Diameter 4.0 mm; Length 200.0 mm Not statedAvailable
PCU040200130β€” Not statedAvailable
PCU040200130Length 200.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040200130Outer Diameter 4.0 mm; Length 200.0 mm Not statedAvailable
PCU040250090Length 250.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040250090Outer Diameter 4.0 mm; Length 250.0 mm Not statedAvailable
PCU040250090β€” Not statedAvailable
PCU040250130β€” Not statedAvailable
PCU040250130Length 250.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040250130Length 250.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040250130Outer Diameter 4.0 mm; Length 250.0 mm Not statedAvailable
PCU040300090Outer Diameter 4.0 mm; Length 300.0 mm Not statedAvailable
PCU040300090β€” Not statedAvailable
PCU040300090Outer Diameter 4.0 mm; Length 300.0 mm Not statedAvailable
PCU040300090Length 300.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040300130Length 300.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040300130Length 300.0 mm; Outer Diameter 4.0 mm Not statedAvailable
PCU040300130β€” Not statedAvailable
PCU040300130Outer Diameter 4.0 mm; Length 300.0 mm Not statedAvailable
PCU050150090Outer Diameter 5.0 mm; Length 150.0 mm Not statedAvailable
PCU050150090Outer Diameter 5.0 mm; Length 150.0 mm Not statedAvailable
PCU050150090β€” Not statedAvailable
PCU050150090Length 150.0 mm; Outer Diameter 5.0 mm Not statedAvailable
PCU050150130Outer Diameter 5.0 mm; Length 150.0 mm Not statedAvailable
PCU050150130Outer Diameter 5.0 mm; Length 150.0 mm Not statedAvailable
PCU050150130β€” Not statedAvailable
PCU050150130Length 150.0 mm; Outer Diameter 5.0 mm Not statedAvailable
PCU050200090Length 200.0 mm; Outer Diameter 5.0 mm Not statedAvailable
PCU050200090Length 200.0 mm; Outer Diameter 5.0 mm Not statedAvailable
PCU050200090β€” Not statedAvailable
PCU050200130Outer Diameter 5.0 mm; Length 200.0 mm Not statedAvailable
PCU050200130β€” Not statedAvailable
PCU050200130Outer Diameter 5.0 mm; Length 200.0 mm Not statedAvailable
PCU050200130Length 200.0 mm; Outer Diameter 5.0 mm Not statedAvailable
PCU050250090Length 250.0 mm; Outer Diameter 5.0 mm Not statedAvailable
PCU050250090Outer Diameter 5.0 mm; Length 250.0 mm Not statedAvailable
PCU050250090β€” Not statedAvailable
PCU050250130Outer Diameter 5.0 mm; Length 250.0 mm Not statedAvailable
PCU050250130β€” Not statedAvailable
PCU050250130Length 250.0 mm; Outer Diameter 5.0 mm Not statedAvailable
PCU050250130Outer Diameter 5.0 mm; Length 250.0 mm Not statedAvailable
PCU050300090β€” Not statedAvailable
PCU050300090Outer Diameter 5.0 mm; Length 300.0 mm Not statedAvailable
PCU050300090Length 300.0 mm; Outer Diameter 5.0 mm Not statedAvailable
PCU050300130Outer Diameter 5.0 mm; Length 300.0 mm Not statedAvailable
PCU050300130Outer Diameter 5.0 mm; Length 300.0 mm Not statedAvailable
PCU050300130Outer Diameter 5.0 mm; Length 300.0 mm Not statedAvailable
PCU050300130β€” Not statedAvailable
PCU060150090Length 150.0 mm; Outer Diameter 6.0 mm Not statedAvailable
PCU060150090Length 150.0 mm; Outer Diameter 6.0 mm Not statedAvailable
PCU060150090β€” Not statedAvailable
PCU060150090Outer Diameter 6.0 mm; Length 150.0 mm Not statedAvailable
PCU060150130β€” Not statedAvailable
PCU060150130Outer Diameter 6.0 mm; Length 150.0 mm Not statedAvailable
PCU060150130Outer Diameter 6.0 mm; Length 150.0 mm Not statedAvailable
PCU060150130Outer Diameter 6.0 mm; Length 150.0 mm Not statedAvailable
PCU060200090β€” Not statedAvailable
PCU060200090Outer Diameter 6.0 mm; Length 200.0 mm Not statedAvailable
PCU060200090Length 200.0 mm; Outer Diameter 6.0 mm Not statedAvailable
PCU060200130Outer Diameter 6.0 mm; Length 200.0 mm Not statedAvailable
PCU060200130Length 200.0 mm; Outer Diameter 6.0 mm Not statedAvailable
PCU060200130β€” Not statedAvailable
PCU060200130Length 200.0 mm; Outer Diameter 6.0 mm Not statedAvailable
PCU060250090Length 250.0 mm; Outer Diameter 6.0 mm Not statedAvailable
PCU060250090β€” Not statedAvailable
PCU060250090Outer Diameter 6.0 mm; Length 250.0 mm Not statedAvailable
PCU060250130Outer Diameter 6.0 mm; Length 250.0 mm Not statedAvailable
PCU060250130Outer Diameter 6.0 mm; Length 250.0 mm Not statedAvailable
PCU060250130β€” Not statedAvailable
PCU060250130Outer Diameter 6.0 mm; Length 250.0 mm Not statedAvailable
PCU060300090Length 300.0 mm; Outer Diameter 6.0 mm Not statedAvailable
PCU060300090Outer Diameter 6.0 mm; Length 300.0 mm Not statedAvailable
PCU060300090β€” Not statedAvailable
PCU060300130Length 300.0 mm; Outer Diameter 6.0 mm Not statedAvailable
PCU060300130β€” Not statedAvailable
PCU060300130Outer Diameter 6.0 mm; Length 300.0 mm Not statedAvailable
PCU060300130Length 300.0 mm; Outer Diameter 6.0 mm Not statedAvailable
PCU070150090Outer Diameter 7.0 mm; Length 150.0 mm Not statedAvailable
PCU070150090Outer Diameter 7.0 mm; Length 150.0 mm Not statedAvailable
PCU070150090β€” Not statedAvailable
PCU070150090Length 150.0 mm; Outer Diameter 7.0 mm Not statedAvailable
PCU070150130Length 150.0 mm; Outer Diameter 7.0 mm Not statedAvailable
PCU070150130Outer Diameter 7.0 mm; Length 150.0 mm Not statedAvailable
PCU070150130β€” Not statedAvailable
PCU070150130Outer Diameter 7.0 mm; Length 150.0 mm Not statedAvailable
PCU070200090β€” Not statedAvailable
PCU070200090Length 200.0 mm; Outer Diameter 7.0 mm Not statedAvailable
PCU070200090Outer Diameter 7.0 mm; Length 200.0 mm Not statedAvailable
PCU070200130Length 200.0 mm; Outer Diameter 7.0 mm Not statedAvailable
PCU070200130β€” Not statedAvailable
PCU070200130Outer Diameter 7.0 mm; Length 200.0 mm Not statedAvailable
PCU070200130Outer Diameter 7.0 mm; Length 200.0 mm Not statedAvailable
PCU070250090β€” Not statedAvailable
PCU070250090Outer Diameter 7.0 mm; Length 250.0 mm Not statedAvailable
PCU070250090Length 250.0 mm; Outer Diameter 7.0 mm Not statedAvailable
PCU070250130Outer Diameter 7.0 mm; Length 250.0 mm Not statedAvailable
PCU070250130β€” Not statedAvailable
PCU070250130Length 250.0 mm; Outer Diameter 7.0 mm Not statedAvailable
PCU070250130Length 250.0 mm; Outer Diameter 7.0 mm Not statedAvailable

FDA clearances

  • 510(k) K103464 December 2010

Procedures that use angioplasty balloons

Frequently asked questions

What is Pacific Xtreme used for?

A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Who makes Pacific Xtreme?

Pacific Xtreme is made by Medtronic, Inc.. It is listed under peripheral angioplasty balloons in our device library.

What sizes does Pacific Xtreme come in?

Sizes listed for Pacific Xtreme: Outer Diameter: 4–7 mm; Length: 150–300 mm. Confirm availability with the manufacturer's instructions for use.

Is Pacific Xtreme MRI safe?

The FDA device database entry for Pacific Xtreme does not state its MRI safety status. Check the labeling before MRI.

Is Pacific Xtreme FDA cleared?

Pacific Xtreme is covered by FDA submission K103464.

How do I contact a Medtronic, Inc. sales representative?

Medtronic, Inc. has not listed representatives on LA Vascular yet. Visit the Medtronic, Inc. company page for contact details.

Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.

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