Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Thrombectomy rotational catheter FDA UDI
- Device Name
- Arrow-Trerotola(TM) Over-The-Wire PTD(R) Rotator Drive Unit FDA UDI
- Model / Reference
- IPN035899 FDA UDI
- Description
- Arrow-Trerotola(TM) Over-The-Wire PTD(R) Rotator Drive Unit FDA UDI
Identifiers
- Catalog Number
- PT-03009-RW FDA UDI
- Primary DI / UDI-DI
- 00801902025302 FDA UDI
- 510(k) Number
- K011056 FDA UDI
- FDA Product Code
- DXE FDA UDI
- GMDN Term
- Thrombectomy rotational catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thrombectomy rotational catheter
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thrombectomy rotational catheter.
- SET Aspirex™ S 8F 85cm — Straub Medical AG · Class II
- Cleaner Plus — Argon Medical Devices, Inc. · Class II
- SET Aspirex™ S 6F 135cm — Straub Medical AG · Class II
- Cleaner15™ Rotational Thrombectomy System — Argon Medical Devices, Inc. · Class II
- Pounce Venous Thrombectomy System — Surmodics, Inc. · Class II
- SET Aspirex™ S 10F 110cm — Straub Medical AG · Class II
- Pounce™ Venous Thrombectomy System — Surmodics, Inc. · Class II
- Cleaner Plus — Argon Medical Devices, Inc. · Class II
Cleared under the same submission
K011056 also covers:
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
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
- Teleflex Incorporated
Sources (1)
- FDA UDI cccae96c-37bc-47a0-85cf-9cb300a305ae 36 fields · synced May 30, 2026