NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
FDA 510(k) clearance K133076 · decided 2014-02-20
Clearance details
- K-number
- K133076
- Device name
- NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
- Applicant
- Neometrics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-30
- Decision date
- 2014-02-20
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- OCY
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene recall (Z-1747-2014) | NEO METRICS, INC. | 2014-06-10 |