Infusion catheters
BASHIR S-B .035 Endovascular Catheter
A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.
BASHIR S-B .035 Endovascular Catheter models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 8101 | Catheter Gauge 8 Fr; Length 10.0 cm | Not stated | Available |
FDA clearances
- 510(k) K231653 July 2023
Procedures that use infusion catheters
Frequently asked questions
What is BASHIR S-B .035 Endovascular Catheter used for?
A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.
Who makes BASHIR S-B .035 Endovascular Catheter?
BASHIR S-B .035 Endovascular Catheter is made by Thrombolex, Inc.. It is listed under thrombolysis infusion catheters, pulmonary embolism devices in our device library.
What sizes does BASHIR S-B .035 Endovascular Catheter come in?
Sizes listed for BASHIR S-B .035 Endovascular Catheter: Catheter Gauge: 8 Fr; Length: 10 cm. Confirm availability with the manufacturer's instructions for use.
Is BASHIR S-B .035 Endovascular Catheter MRI safe?
The FDA device database entry for BASHIR S-B .035 Endovascular Catheter does not state its MRI safety status. Check the labeling before MRI.
Is BASHIR S-B .035 Endovascular Catheter FDA cleared?
BASHIR S-B .035 Endovascular Catheter is covered by FDA submission K231653.
How do I contact a Thrombolex, Inc. sales representative?
Thrombolex, Inc. has not listed representatives on LA Vascular yet. Visit the Thrombolex, 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.