510(k) K943934 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
AORTIC ARCH CANNULAS
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Jun 2, 1995 |
| Received | Aug 12, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943934
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2017 | Sorin Group USA, Inc. Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile
Product Usage:
The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary by Terminated |
DWF | None listed |
| Sep 8, 2016 | Sorin Group USA, Inc. Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypas Terminated |
DWF | None listed |
| Jul 8, 2016 | Sorin Group USA, Inc. AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8)
Aortic Arch Cannulae are designed to be used in the extracorporeal circuit durin Terminated |
DWF | None listed |
| Feb 16, 2016 | Sorin Group USA, Inc. Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Car Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.