ASCEND BALLOON DAILATION CATHETER
FDA 510(k) clearance K970041 · decided 1997-03-19
Clearance details
- K-number
- K970041
- Device name
- ASCEND BALLOON DAILATION CATHETER
- Applicant
- Cook Urological, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-06
- Decision date
- 1997-03-19
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- EZN
- Device class
- 2
- Regulation number
- 876.5470
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.