GTX 12 GIDEWIRE
FDA 510(k) clearance K100470 · decided 2010-04-21
Clearance details
- K-number
- K100470
- Device name
- GTX 12 GIDEWIRE
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-02-18
- Decision date
- 2010-04-21
- Days to decision
- 62 days
- Clearance type
- Special
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ProVia CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV3 recall (Z-0264-2014) | Medtronic Vascular | 2013-11-15 |
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|---|---|---|
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