Identity
- Trade Name
- PX400 Microcatheter FDA UDI
- Generic Name
- Vascular microcatheter FDA UDI
- Device Name
- Penumbra Cat 025 45Deg FDA UDI
- Model / Reference
- PX40045-A FDA UDI
- Description
- Penumbra Cat 025 45Deg FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814548011622 FDA UDI
- 510(k) Number
- K100826 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Vascular microcatheter 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: Vascular microcatheter
PX400 Microcatheter by Penumbra, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular microcatheter.
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- SUPERCROSS — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K100826 also covers:
- PX SLIM Delivery Microcatheter — PENUMBRA, INC.
- PX SLIM Delivery Microcatheter — PENUMBRA, INC.
- PX SLIM Delivery Microcatheter — PENUMBRA, INC.
- PX SLIM Delivery Microcatheter — PENUMBRA, INC.
- PX SLIM Delivery Microcatheter — PENUMBRA, INC.
- PX SLIM Delivery Microcatheter — PENUMBRA, INC.
- PX SLIM Delivery Microcatheter — PENUMBRA, INC.
- PX SLIM Delivery Microcatheter — PENUMBRA, INC.
- PX SLIM Delivery Microcatheter — PENUMBRA, INC.
- PX SLIM Delivery Microcatheter — PENUMBRA, INC.
- PX SLIM Delivery Microcatheter — PENUMBRA, INC.
- PX SLIM Delivery Microcatheter — 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 27317522-8f12-4d7e-935f-025db1fab891 34 fields · synced May 30, 2026