MARDIS DANGLER URETERAL STENT SET
FDA 510(k) clearance K860267 · decided 1986-04-03
Clearance details
- K-number
- K860267
- Device name
- MARDIS DANGLER URETERAL STENT SET
- Applicant
- Van-Tec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-27
- Decision date
- 1986-04-03
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- FAD
- Device class
- 2
- Regulation number
- 876.4620
- 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 |
|---|---|---|
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DES recall (Z-1342-2009) | Boston Scientific Corporation | 2009-05-21 |