ClearanceBrief
510(k) K771499 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

FLEXIBLE ARTERIAL CANNULAE

Applicant3M Health Care, Sarns, Mchenry IL, US
DecisionSubstantially Equivalent, Aug 16, 1977
ReceivedAug 5, 1977
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K771499

DateFirm and productCodeLinked 510(k)
Jul 23, 2014Terumo Cardiovascular Systems Corporation
Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Th
Terminated
DWFNone listed
Jan 11, 2013Terumo 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
DWFNone listed
Jan 11, 2013Terumo 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
DWFNone listed
Jan 11, 2013Terumo 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
DWFNone listed
Jan 11, 2013Terumo 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
DWFNone listed
Jan 11, 2013Terumo 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
DWFNone listed
Jan 11, 2013Terumo 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
DWFNone listed
Jun 20, 2012Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta
Terminated
DWFNone listed
Jun 20, 2012Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta
Terminated
DWFNone listed
Jun 20, 2012Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta du
Terminated
DWFNone listed
Jun 20, 2012Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta
Terminated
DWFNone listed
Nov 26, 2005Terumo Cardiovascular Systems Corp
Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only.
Terminated
DWFNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.