Panels › Gastroenterology, Urology › Product code FFA · Class 2
Tube, Drainage, Suprapubic
Regulation 876.5090
0510(k)s in 12 months (3 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in FFA
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 1 | 10 |
| Concept, Inc. | 1 | 0 |
| New England Surgical Instrument Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2024 | Boston Scientific Corporation VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract. Open, Classified |
FFA | K211934 |
| Sep 13, 2024 | Boston Scientific Corporation vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections. Open, Classified |
FFA | K211934 |
| Sep 13, 2024 | Boston Scientific Corporation Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract. Open, Classified |
FFA | K211934 |
| Sep 13, 2024 | Boston Scientific Corporation Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail Open, Classified |
FFA | K211934 |
| Sep 13, 2024 | Boston Scientific Corporation Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail Open, Classified |
FFA | K211934 |
| 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 | K944290 |
| 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 | K944290 |
| 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 | K944290 |
| 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 | K944290 |
| 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 | K944290 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.