BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C
FDA 510(k) clearance K990072 · decided 1999-03-25
Clearance details
- K-number
- K990072
- Device name
- BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C
- Applicant
- Cook Urological, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-11
- Decision date
- 1999-03-25
- Days to decision
- 73 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
| Record | Firm | Date |
|---|---|---|
| Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0 recall (Z-0554-03) | Cook Urological, Inc. | 2003-02-13 |
| Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0 recall (Z-0555-03) | Cook Urological, Inc. | 2003-02-13 |