Identity
- Trade Name
- Drivewire SR FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire Guidewire is intended to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. FDA UDI
- Model / Reference
- DRSR7463 FDA UDI
- Description
- The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire Guidewire is intended to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290015107242 FDA UDI
- 510(k) Number
- K200374 FDA UDI
- FDA Product Code
- MOF FDA UDIDQX FDA UDI
- GMDN Term
- Cardiac/peripheral vascular guidewire, single-use 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac/peripheral vascular guidewire, single-use
Drivewire SR by Rapid Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200374 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
- Rapid Medical Inc.
Sources (1)
- FDA UDI dd426379-e713-49bb-9c04-822026e6b41d 35 fields · synced May 30, 2026