Penumbra, Inc.
35 product lines across 6 device categories: Coils, Thrombectomy devices, Microcatheters, Neuro aspiration catheters, PE devices, Stent retrievers.
Embolization Coils
Used in: Uterine Artery Embolization (UAE), Prostate Artery Embolization (PAE), Ovarian Vein Embolization, Varicocele Embolization, Portal Vein Embolization, TIPS (Transjugular Intrahepatic Portosystemic Shunt)
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Penumbra Coil 400 PC400 J Sft, 3cm | Length: 1β60 cm | 320 | MR Conditional |
| Smart Coil 400SMTSTD4H20 | Length: 10 cm | 238 | MR Conditional |
| RUBY Coil PC400 Cplx Std, 3x5 | β | 111 | MR Conditional |
| LP Coil System Packing Coil LP, 3cm | Length: 1β70 cm | 77 | MR Conditional |
| Swift Coil System SwiftPAC Coil, 12 cm | Length: 1β60 cm | 36 | MR Conditional |
| Ruby XL Coil System POD XL, 10mm x 55cm | Length: 10β70 cm | 23 | MR Conditional |
| POD Packing Packing Coil 50cm | Length: 2β55 cm | 15 | MR Conditional |
| swiftMATCH Coil, Extra Soft swiftMATCH Coil, Extra Soft, 2mm x 4cm | Length: 1β10 cm | 13 | MR Conditional |
| POD RBYPODJ15 | β | 8 | Not stated |
| swiftMATCH Coil, Soft swiftMATCH Coil, Soft, 4mm x 10cm | Length: 6β15 cm | 5 | MR Conditional |
| Penumbra System SmtCoil Handle | β | 2 | Not stated |
| RUBY Ruby Standard, 20mm x 60cm | Length: 60 cm | 1 | MR Conditional |
Mechanical Thrombectomy Devices
Used in: DVT Mechanical Thrombectomy, Pulmonary Embolism Thrombectomy, Dialysis Graft and Fistula Thrombectomy
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Indigo System CAT16 HTORQ 115cm, Select + 135cm BER Tip, Lightning Flash 2.0 Tubing | Length: 50β190 cm | 75 | Not stated |
| Indigo System Lightning Bolt 16 Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select+ 100cm H1 Tip | Length: 80β135 cm | 4 | Not stated |
| Indigo System Lightning Flash Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select+ 100cm H1 Tip | Length: 80β135 cm | 4 | Not stated |
| Indigo Aspiration Catheter D Kit | β | 3 | Not stated |
Microcatheters
Used in: Uterine Artery Embolization (UAE), Prostate Artery Embolization (PAE), Genicular Artery Embolization (GAE), Ovarian Vein Embolization, Varicocele Embolization, Transarterial Chemoembolization (TACE)
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Neuron Neur6F, 125H1 | Length: 105β125 cm | 57 | Not stated |
| Benchmark MAX System BMX81 105cm, 5F SIM 130cm Select | Length: 80β130 cm | 42 | Not stated |
| Benchmark Bmk70 STR, 130H1, 105cm | Length: 95β130 cm | 38 | Not stated |
| PX SLIM Delivery Microcatheter PXSLIMSTR-A | β | 15 | Not stated |
| Lantern Delivery Catheter PXSLIMLAN160T90 | β | 12 | Not stated |
| Velocity Delivery Microcatheter AdvPX400 J 160MB | β | 8 | Not stated |
| ACCESS25 Delivery Microcatheter ACCESS25 150Mirco, 45Deg | β | 4 | Not stated |
| PX400 Microcatheter Penumbra Cat 025 STR | β | 4 | Not stated |
| Penumbra System | β | 2 | Not stated |
Neurovascular Aspiration Catheters
Used in: Stroke Thrombectomy
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Penumbra System JET7 Kit, 138 cm, no CE | Length: 115β160 cm | 102 | Not stated |
| RED 43 Reperfusion Catheter RED 43 Kit, 162cm, 110 Tubing, no CE | Length: 136β167 cm | 18 | Not stated |
| RED 68 Reperfusion Catheter RED 68, 132cm | Length: 132 cm | 9 | Not stated |
| RED 72 Reperfusion Catheter RED 72 KIT, 132cm | Length: 132 cm | 6 | Not stated |
| RED RED 62 Kit, 138cm, Jon Snow Tubing | Length: 138 cm | 2 | Not stated |
Pulmonary Embolism Devices
Used in: Pulmonary Embolism Thrombectomy
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Indigo System CAT16 HTORQ 115cm, Select + 135cm BER Tip, Lightning Flash 2.0 Tubing | Length: 50β190 cm | 75 | Not stated |
| Indigo System Lightning Bolt 16 Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select+ 100cm H1 Tip | Length: 80β135 cm | 4 | Not stated |
| Indigo System Lightning Flash Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select+ 100cm H1 Tip | Length: 80β135 cm | 4 | Not stated |
| Indigo Aspiration Catheter D Kit | β | 3 | Not stated |
Stent Retrievers for Stroke
Used in: Stroke Thrombectomy
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Penumbra System 3d Revascularization Device | β | 1 | Not stated |
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FDA clearances and approvals
- indigo r aspiration system lightning flash aspiration tubing indigo r aspiration system lightning bolt aspiration tubing 510K K252612, 2025
- penumbra system reperfusion catheter red 72 510K K242104, 2025
- indigo r lightning flash aspiration system select catheter 510K K241399, 2024
- indigo r aspiration system - lightning r flash 510K K240030, 2024
- penumbra lp coil system 510K K230284, 2023
- indigo r aspiration system lightning bolt aspiration tubing 510K K223186, 2023
- penumbra system reperfusion catheter red 43 510K K222808, 2022
- indigo aspiration system - lightning flash 510K K222358, 2022
- penumbra system reperfusion catheter red 72 510K K211654, 2021
- penumbra system red 68 reperfusion catheter 510K K211411, 2021
- penumbra system reperfusion catheter red 62 510K K203440, 2021
- indigo aspiration system - lightning aspiration tubing 510K K210323, 2021
- indigo system aspiration catheter 7 indigo aspiration system separator 7 lightning 7 510K K210083, 2021
- indigo aspiration system - aspiration catheter 12 and separator 12 510K K202821, 2020
- indigo aspiration system - aspiration catheter 7 and separator 7 510K K193595, 2020
- benchmark bmx96 access system 510K K201271, 2020
- indigo system aspiration catheter 12 indigo aspiration system separator 12 510K K192981, 2020
- indigo aspiration system lightning aspiration tubing 510K K200771, 2020
- indigo aspiration system lightning aspiration tubing 510K K193244, 2020
- penumbra system penumbra jet 7x 510K K191946, 2020
Product lines, models and sizes are compiled from the FDA Global Unique Device Identification Database (GUDID) and FDA clearance records. Descriptions marked "Provided by the manufacturer" come from the company and are reviewed before publishing.