Product code LWR ยท Class 3
Heart-Valve, Non-Allograft Tissue
0510(k)s in 12 months (0 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in LWR
| Company | 510(k)s | Recalls |
|---|---|---|
| Sorin Group Italia S.r.l. | 0 | 5 |
| Medtronic Cardiovascular Surgery-the Heart Valve Division | 0 | 1 |
| Sorin Group USA, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2020 | Sorin Group Italia S.r.l. Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to redu Terminated |
LWR | None listed |
| Jul 29, 2020 | Sorin Group Italia S.r.l. Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used t Terminated |
LWR | None listed |
| Jul 29, 2020 | Sorin Group Italia S.r.l. Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to Terminated |
LWR | None listed |
| Jul 29, 2020 | Sorin Group Italia S.r.l. Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to Terminated |
LWR | None listed |
| Jul 29, 2020 | Sorin Group Italia S.r.l. Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used Terminated |
LWR | None listed |
| Oct 31, 2016 | Sorin Group USA, Inc. Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item Terminated |
LWR | None listed |
| Feb 3, 2014 | Medtronic Cardiovascular Surgery-the Heart Valve Division Product Name: Model 7305- Mosaic Aortic Obturator
The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses. Terminated |
LWR | None listed |
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