Panels › Gastroenterology, Urology › Product code NFK · Class 2
Kit, Repair, Catheter, Hemodialysis
Regulation 876.5540
0510(k)s in 12 months (11 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in NFK
| Company | 510(k)s | Recalls |
|---|---|---|
| Medical Components, Inc dba MedComp | 0 | 10 |
| C.R. Bard, Inc. | 5 | 0 |
| Arrow International Inc | 0 | 2 |
| Spire Biomedical, Inc. | 2 | 0 |
| Diatek, Inc. | 1 | 0 |
| Kendall | 1 | 0 |
| Medcomp | 1 | 0 |
| Medical Components, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2020 | Arrow International Inc NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged. Terminated |
NFK | K020430 |
| Jul 6, 2020 | Arrow International Inc Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged. Terminated |
NFK | K020430 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp REPAIR KIT, REF RPK-01, UDI 884908039856
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimu Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp 12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairi Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extension Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp 12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairi Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp 12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairin Terminated |
NFK | K981125 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp 12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairin Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp REPAIR KIT, REF ARA101, UDI 884908083637
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her
connectors, clamps, or repairing extensions where there Terminated |
NFK | K022570 |
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