CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
FDA 510(k) clearance K071189 · decided 2007-05-16
Clearance details
- K-number
- K071189
- Device name
- CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
- Applicant
- Cordis Europa, N.V.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-30
- Decision date
- 2007-05-16
- Days to decision
- 16 days
- Clearance type
- Special
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Roden, Drenthe, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.