FLEXIMA BILIARY CATHETER
FDA 510(k) clearance K023870 · decided 2002-12-20
Clearance details
- K-number
- K023870
- Device name
- FLEXIMA BILIARY CATHETER
- Applicant
- Boston Scientific/Medi-Tech
- Decision
- Substantially Equivalent
- Date received
- 2002-11-20
- Decision date
- 2002-12-20
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm recall (Z-1901-2009) | Boston Scientific Corporation | 2009-08-27 |
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DES recall (Z-1337-2009) | Boston Scientific Corporation | 2009-05-21 |