510(k) K083301 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS
| Applicant | Terumo Cardiovascular Systems Corp., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Dec 18, 2008 |
| Received | Nov 10, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083301
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating
Product Usage: The Venous Return Cannula is indicated for venous drainage durin Terminated |
DWF | None listed |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating
Product Usage: The Venous Return Cannula is indicated for venous dra Terminated |
DWF | None listed |
| 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: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 12" (31 em) long.
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the as Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long.
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the as Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long, with X Coating surface coating.
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicat Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long.
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the as Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long, with X Coating" surface coating.
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicat Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr) OD with 3/8" connector, 8.75" (22cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns"Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with 0580178 luer port 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer port 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm)
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is i Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns"Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector, 14" (36cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated f Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector, 14" (36cm) long, with Xcoating"surface coating
Product Usage: CTS Usage:
The Sarn Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector, 14" (36cm) long, with Xcoating"surface coating
Product Usage: CTS Usage:
The Sarn Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip with luer port 80mm (24Fr) 00 with 3/8" connector,12" (31cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for u Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip 8.0mm (24Fr) 0D with 3/8" connector, 12" (31cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for use In perfusi Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer port 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 8.0mm (24Fr) OD with 3/8" connector, 12" (31 cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr) OD with 3/8" connector, 12" (31cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for us Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced 7.0mm (21 Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer port 7.0mm (21 Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage:
The Sarns-Aortic Cannula is indicated Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 7.0mm (21 Fr) OD with 3/8" connector, 12" (31cm) lonq
Product Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the asc Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 7.0mm (21 Fr) OD with 3/8" connector, 12" (31cm) long
Product Usage:
The Sarns-Aortic Cannula is indicated for use In perfu Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 6.0mm (18Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage:
The Sarns-Aortic Cannula is indicated for use In p Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer port 6.0mm (18Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage:
The Sarns-Aortic Cannula is indicat Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer port 6.0mm (18Fr) OD with 3/8" connector, 14" (36cm) long, with Xcoating" surface coating
Product Usage:
The Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer port 6.0mm (18Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage:
The Sarns-Aortic Cannula is indicated Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Glendale Memorial XCoated Pack
Product Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to red Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Glendale Memorial XCoated Pack
Product Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to red Terminated |
DWF | None listed |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Glendale Memorial Fx Pack
Product Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce t Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.