PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE
FDA 510(k) clearance K023700 · decided 2002-12-04
Clearance details
- K-number
- K023700
- Device name
- PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE
- Applicant
- Precision Vascular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-04
- Decision date
- 2002-12-04
- 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
- West Valley City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm len recall (Z-1909-2024) | Stryker Neurovascular | 2024-05-28 |