510(k) K944290 ยท FFA Tube, Drainage, Suprapubic
CATHETERS, BILIARY CATHETERS, UROLOGICAL
| Applicant | Boston Scientific Corp, Spencer IN, US |
| Decision | Substantially Equivalent, Dec 8, 1994 |
| Received | Sep 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944290
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN DESCRIPTION
M001271770 FLEXIMA NEPH FIRM 8F/25CM
M0012 Terminated |
FFA | None listed |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN DESCRIPTION
M001271240 FLEXIMA APDL FIRM 10F/25CM
M0012 Terminated |
FFA | None listed |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN DESCRIPTION
M001271540 FLEXIMA BILIARY FIRM 8F/35CM
M001 Terminated |
FFA | None listed |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
435428-01 M001273030 FLEXIMA VSCL REG 12FR/35 Terminated |
FFA | None listed |
| Oct 28, 2006 | Boston Scientific Corp Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350. Terminated |
FFA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.