Identity
- Trade Name
- SilverSpeedTM FDA UDI
- Generic Name
- Peripheral vascular guidewire, manual FDA UDI
- Device Name
- 103-0602-200 SILVERSPEED14 GWIRE ATH FDA UDI
- Model / Reference
- 103-0602-200 FDA UDI
- Description
- 103-0602-200 SILVERSPEED14 GWIRE ATH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847536004566 FDA UDI
- 510(k) Number
- K124007 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- Peripheral vascular guidewire, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1330 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: Peripheral vascular guidewire, manual
SilverSpeedTM by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral vascular guidewire, manual.
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- Cook — COOK INCORPORATED · Class II
- Selectiva — HERAEUS MEDICAL COMPONENTS LLC · Class II
Cleared under the same submission
K124007 also covers:
- Mirage — Micro Therapeutics, Inc.
- MirageTM — Micro Therapeutics, Inc.
- MirageTM — Micro Therapeutics, Inc.
- SilverSpeedTM — Micro Therapeutics, Inc.
- SilverSpeedTM — Micro Therapeutics, Inc.
- SilverSpeedTM — Micro Therapeutics, Inc.
- SilverSpeedTM — Micro Therapeutics, Inc.
- SilverSpeedTM — Micro Therapeutics, Inc.
- SilverSpeedTM — Micro Therapeutics, Inc.
- SilverSpeedTM — Micro Therapeutics, Inc.
- X-Pedion — Micro Therapeutics, Inc.
- X-celeratorTM — Micro Therapeutics, 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
- Micro Therapeutics, Inc.
Sources (1)
- FDA UDI 5744cb58-7762-46b1-8f12-5e93cf0dfce1 36 fields · synced May 30, 2026