DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY
FDA 510(k) clearance K093822 · decided 2010-01-28
Clearance details
- K-number
- K093822
- Device name
- DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY
- Applicant
- Shepherd Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-12-14
- Decision date
- 2010-01-28
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- La Jolla, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.