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Penumbra System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref PST2Model Suction/irrigation tubing, single-use
Identity
- Trade Name
- MAX Aspiration Tubing EUDAMEDPenumbra System FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- Penumbra and INDIGO Aspiration Tubing EUDAMEDPS MAX Aspiration Tubing FDA UDI
- Model / Reference
- PST2 EUDAMEDFDA UDISuction/irrigation tubing, single-use EUDAMED
- Description
- PS MAX Aspiration Tubing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810169721094 EUDAMED00814548012025 FDA UDI
- Basic UDI-DI
- 081454801PSINDTUB3G EUDAMED
- 510(k) Number
- K113163 FDA UDI
- FDA Product Code
- NRY FDA UDI
- EMDN Code
- C010402020702 MECHANICAL PERIPHERAL THROMBECTOMY AND THROMBOASPIRATION SYSTEMS EUDAMED
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thrombectomy suction catheter
Penumbra System by Penumbra, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Thrombectomy suction catheter.
- Symphony™ ProHelix™ — IMPERATIVE CARE INC. · Class II
- Prodigy™ Catheter — IMPERATIVE CARE INC. · Class II
- Symphony™ Advance™ Long Dilator — IMPERATIVE CARE INC. · Class II
- Trevo — Stryker Corp.
- Pounce ™ Thrombectomy — Surmodics, Inc. · Class II
- Solitaire™ — Micro Therapeutics, Inc. · Class II
- Stroke Fast Pack — Stryker Corp.
- SmartClaw™ — Boston Scientific · Class II
Cleared under the same submission
K113163 also covers:
- JET — PENUMBRA, INC.
- JET — PENUMBRA, INC.
- JET — PENUMBRA, INC.
- JET — PENUMBRA, INC.
- Penumbra System — PENUMBRA, INC.
- Penumbra System — PENUMBRA, INC.
- Penumbra System — PENUMBRA, INC.
- Penumbra System — PENUMBRA, INC.
- Penumbra System — PENUMBRA, INC.
- Penumbra System — PENUMBRA, INC.
- Penumbra System — PENUMBRA, INC.
- Penumbra System — PENUMBRA, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (2)
- FDA UDI 07567a5a-e01f-470c-bf99-1e5c1395da8f 34 fields · synced Jul 12, 2026
- EUDAMED 63bace45-7300-4d68-8454-ad633d776f19 61 fields · synced Jun 14, 2026