510(k) K023870 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
FLEXIMA BILIARY CATHETER
| Applicant | Boston Scientific/Medi-Tech, Natick, MA, US |
| Decision | Substantially Equivalent, Dec 20, 2002 |
| Received | Nov 20, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023870
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2009 | Boston Scientific Corporation Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M0012726 Terminated |
FGE | None listed |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001272600 FLEXIMA BILIARY REG RO 8F/35CM
M0 Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.