510(k) K770429 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
CANNULAE, AORTIC, ARCH, HIGH FLOW
| Applicant | 3M Health Care, Sarns, Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 16, 1977 |
| Received | Mar 7, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K770429
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2013 | Terumo Cardiovascular Systems Corporation Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long
The Sarns" High Flow Aortic Arch Cannula and Sa Terminated |
DWF | None listed |
| Jan 11, 2013 | Terumo Cardiovascular Systems Corporation Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long
The Sarns" High Flow Aortic Arch Cannula and Sarn Terminated |
DWF | None listed |
| Jan 11, 2013 | Terumo Cardiovascular Systems Corporation Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long
The Sarns" High Flow Aortic Arch Cannula and Sarns&a Terminated |
DWF | None listed |
| Jan 11, 2013 | Terumo Cardiovascular Systems Corporation Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long
The Sarns" High Flow Aortic Arch Cannula and Sarns&amp Terminated |
DWF | None listed |
| Jan 11, 2013 | Terumo Cardiovascular Systems Corporation Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long
The Sarns" High Flow Aortic Arch Cannula and Sarns& Terminated |
DWF | None listed |
| Jan 11, 2013 | Terumo Cardiovascular Systems Corporation Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface
The Sarns" High Flow Aortic Arch Ca Terminated |
DWF | None listed |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during Terminated |
DWF | None listed |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during c Terminated |
DWF | None listed |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation 24FR FLEX ART CANN NON STERILE.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Terminated |
DWF | None listed |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation SPECIALTYCARE - HUDGENS.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Terminated |
DWF | None listed |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation CUSTOM CPB CATHETER KIT-DR.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Terminated |
DWF | None listed |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation CPB CATHETER KIT- DR.VAN TRIGHT.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.