GALT MEDICAL GUIDEWIRE
FDA 510(k) clearance K021990 · decided 2002-07-18
Clearance details
- K-number
- K021990
- Device name
- GALT MEDICAL GUIDEWIRE
- Applicant
- Galt Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-18
- Decision date
- 2002-07-18
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Garland, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-0 recall (Z-2917-2026) | Galt Medical Corporation | 2026-08-07 |