510(k) K934127 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
SARNS LOW JETTING AORTIC ARCH CANNULA
| Applicant | 3M Health Care, Sarns, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Feb 22, 1994 |
| Received | Aug 25, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934127
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating,
Product Usage:
The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmona Terminated |
DWF | None listed |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating
Product Usage:
The Aortic Cannula is indicated for use in perfusion of the a Terminated |
DWF | None listed |
| Nov 8, 2013 | Terumo Cardiovascular Systems Corporation Sarns" Soft-Flow Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long.
Indicated for use in perfu Terminated |
DWF | None listed |
| Nov 8, 2013 | Terumo Cardiovascular Systems Corporation Sarns" Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 cm) long.
Indicated for use in per Terminated |
DWF | None listed |
| Nov 8, 2013 | Terumo Cardiovascular Systems Corporation Sarns" Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long.
Indicated for use in per Terminated |
DWF | None listed |
| Nov 8, 2013 | Terumo Cardiovascular Systems Corporation Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long.
Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena c Terminated |
DWF | None listed |
| Dec 3, 2012 | Terumo Cardiovascular Systems Corporation 24 Fr 8mm Sft Flow Str Wire W/L
The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours Terminated |
DWF | None listed |
| Dec 3, 2012 | Terumo Cardiovascular Systems Corporation 24 Fr 8mm Sft Flow Straight
The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of u Terminated |
DWF | None listed |
| Dec 3, 2012 | Terumo Cardiovascular Systems Corporation 18 Fr 6mm Sft Flow Angled Wire
The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours o Terminated |
DWF | None listed |
| Dec 3, 2012 | Terumo Cardiovascular Systems Corporation 18 Fr 6mm Sft Flow Ang Wire W/L
The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours Terminated |
DWF | None listed |
| Dec 3, 2012 | Terumo Cardiovascular Systems Corporation 24 Fr 8mm Soft Flow Ang Wire W/L
The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours Terminated |
DWF | None listed |
| Dec 3, 2012 | Terumo Cardiovascular Systems Corporation 24 Fr 8mm Soft Flow Ang W/L
The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of u 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 |
| Nov 23, 2005 | Terumo Cardiovascular Systems Corp Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 inch connector, 14 inches (35 cm) long; catalog number 7080. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.