Product code NKM ยท Class 3
Mitral Valve Repair Devices
0510(k)s in 12 months (0 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in NKM
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Vascular | 0 | 5 |
| Edwards Lifesciences, LLC | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2023 | Edwards Lifesciences, LLC PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS Open, Classified |
NKM | None listed |
| Oct 20, 2022 | Abbott Vascular Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT,
MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW,
MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT,
MitraClip G4 CDS XTW REPAIR-MR Open, Classified |
NKM | None listed |
| Oct 20, 2022 | Abbott Vascular Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR,
MitraClip NTR Clip Delivery System CE/CDS0602-NTR,
MitraClip XTR Clip Delivery System CE/CDS0602-XTR,
MitraClip G4 Clip Delivery System Open, Classified |
NKM | None listed |
| Oct 20, 2022 | Abbott Vascular Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR,
MitraClip G4 Clip Delivery System NT US/CDS0701-NT,
MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW,
MitraClip G4 Clip Delivery Sy Open, Classified |
NKM | None listed |
| May 1, 2019 | Abbott Vascular Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only Terminated |
NKM | None listed |
| Mar 7, 2016 | Abbott Vascular MitraClip Clip Delivery System, product number MSK0101. The MitraClip System
contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product nu Terminated |
NKM | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.