Identity
- Trade Name
- Penumbra System FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- PS Separator 054 FDA UDI
- Model / Reference
- PSS054 FDA UDI
- Description
- PS Separator 054 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814548010380 FDA UDI
- 510(k) Number
- K090752 FDA UDI
- FDA Product Code
- NRY FDA UDI
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 — FDA UDI — listed in FDA GUDID — 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
K090752 also covers:
- 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.
- Penumbra System — PENUMBRA, INC.
- Penumbra System — PENUMBRA, INC.
- Penumbra System — PENUMBRA, INC.
- Penumbra System — PENUMBRA, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA UDI b083248a-dd16-4f07-a6e1-a23f8fd0ce24 34 fields · synced May 30, 2026