Identity
- Trade Name
- SilverHawkTM FDA UDI
- Generic Name
- Mechanical atherectomy system catheter, peripheral FDA UDI
- Device Name
- ATHERECTOMY P4055 SILVERHAWK ATK V03 FDA UDI
- Model / Reference
- P4055 FDA UDI
- Description
- ATHERECTOMY P4055 SILVERHAWK ATK V03 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821684074145 FDA UDI
- 510(k) Number
- K061188 FDA UDI
- FDA Product Code
- MCW FDA UDI
- GMDN Term
- Mechanical atherectomy system catheter, peripheral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4875 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Mechanical atherectomy system catheter, peripheral
SilverHawkTM by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical atherectomy system catheter, peripheral.
- Stealth — Cardiovascular Systems, Inc. · Class II
- Kittykat II — AVINGER, INC. · Class II
- DIAMONDBACK — Cardiovascular Systems, Inc. · Class II
- Stealth — Cardiovascular Systems, Inc. · Class II
- Diamondback Peripheral — Cardiovascular Systems, Inc. · Class II
- Stealth — Cardiovascular Systems, Inc. · Class II
- Diamondback Peripheral — Cardiovascular Systems, Inc. · Class II
- Lightbox L3 — AVINGER, INC. · Class II
Cleared under the same submission
K061188 also covers:
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
- Covidien LP
Sources (1)
- FDA UDI 3b034c3e-adfd-4c28-890d-64b25cda5819 36 fields · synced Jun 1, 2026