Destino Reach
FDA 510(k) clearance K151951 · decided 2015-09-22
Clearance details
- K-number
- K151951
- Device name
- Destino Reach
- Applicant
- Oscor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-07-15
- Decision date
- 2015-09-22
- Days to decision
- 69 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Palm Harbor, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.