ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
FDA 510(k) clearance K022552 · decided 2002-09-27
Clearance details
- K-number
- K022552
- Device name
- ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
- Applicant
- Cook, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-08-02
- Decision date
- 2002-09-27
- Days to decision
- 56 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.