EXPEL APD DRAINAGE CATHETER SYSTEM
FDA 510(k) clearance K141335 · decided 2014-10-17
Clearance details
- K-number
- K141335
- Device name
- EXPEL APD DRAINAGE CATHETER SYSTEM
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2014-05-21
- Decision date
- 2014-10-17
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Bi recall (Z-1355-2015) | Boston Scientific Corporation | 2015-03-31 |
| Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and recall (Z-1336-2015) | Boston Scientific Corporation | 2015-03-27 |