CavaClear Laser Sheath
FDA 510(k) clearance DEN210024 · decided 2021-12-21
Clearance details
- K-number
- DEN210024
- Device name
- CavaClear Laser Sheath
- Applicant
- Spectranetics, Inc.
- Decision
- Unknown
- Date received
- 2021-06-25
- Decision date
- 2021-12-21
- Days to decision
- 179 days
- Clearance type
- Direct
- Product code
- QRJ
- Device class
- 2
- Regulation number
- 870.5125
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Colorado Springs, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.