Zoom 14 Guidewire
FDA 510(k) clearance K201760 · decided 2020-07-29
Clearance details
- K-number
- K201760
- Device name
- Zoom 14 Guidewire
- Applicant
- Scientia Vascular, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-06-29
- Decision date
- 2020-07-29
- 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
No recalls on record reference this clearance.