Atlas FDA

SARNS LOW JETTING AORTIC ARCH CANNULA

FDA 510(k) clearance K934127 · decided 1994-02-22

Clearance details

K-number
K934127
Device name
SARNS LOW JETTING AORTIC ARCH CANNULA
Applicant
3M Health Care, Sarns
Decision
Substantially Equivalent
Date received
1993-08-25
Decision date
1994-02-22
Days to decision
181 days
Clearance type
Traditional
Product code
DWF
Device class
2
Regulation number
870.4210
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Ann Arbor, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Pr recall (Z-2099-2014)Terumo Cardiovascular Systems Corporation2014-07-23
Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with recall (Z-2105-2014)Terumo Cardiovascular Systems Corporation2014-07-23
Sarns" Soft-Flow Aortic Cannula without Suture Flange, angled tip, wire-reinforced with lu recall (Z-0193-2014)Terumo Cardiovascular Systems Corporation2013-11-08
Sarns" Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with recall (Z-0194-2014)Terumo Cardiovascular Systems Corporation2013-11-08
Sarns" Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with recall (Z-0195-2014)Terumo Cardiovascular Systems Corporation2013-11-08
Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for ve recall (Z-0196-2014)Terumo Cardiovascular Systems Corporation2013-11-08
24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion recall (Z-0456-2013)Terumo Cardiovascular Systems Corporation2012-12-03
24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of recall (Z-0458-2013)Terumo Cardiovascular Systems Corporation2012-12-03
18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in perfusion recall (Z-0459-2013)Terumo Cardiovascular Systems Corporation2012-12-03
18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion recall (Z-0460-2013)Terumo Cardiovascular Systems Corporation2012-12-03
24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusio recall (Z-0461-2013)Terumo Cardiovascular Systems Corporation2012-12-03
24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of recall (Z-0462-2013)Terumo Cardiovascular Systems Corporation2012-12-03
Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 12" recall (Z-1287-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" recall (Z-1288-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" recall (Z-1289-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" recall (Z-1290-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" recall (Z-1291-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr) O recall (Z-1292-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns"Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with 0580 recall (Z-1293-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer recall (Z-1294-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns"Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24 recall (Z-1295-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24 recall (Z-1296-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24 recall (Z-1297-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula without suture flange Angled tip with luer port 80mm (24Fr) recall (Z-1298-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula without suture flange Angled tip 8.0mm (24Fr) 0D with 3/8" recall (Z-1299-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced 8.0mm (24Fr) recall (Z-1300-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer po recall (Z-1301-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 8.0mm (24Fr) OD with 3/8" con recall (Z-1302-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr) O recall (Z-1303-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced 7.0mm (21 Fr recall (Z-1304-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer po recall (Z-1305-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 7.0mm (21 Fr) OD with 3/8" co recall (Z-1306-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 7.0mm (21 Fr) recall (Z-1307-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 6.0mm (18 recall (Z-1308-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer recall (Z-1309-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer recall (Z-1310-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer po recall (Z-1311-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Glendale Memorial XCoated Pack Product Usage: The Sarns-Aortic Cannula is indicated for us recall (Z-1312-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Glendale Memorial XCoated Pack Product Usage: The Sarns-Aortic Cannula is indicated for us recall (Z-1313-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Glendale Memorial Fx Pack Product Usage: The Sarns-Aortic Cannula is indicated for use In recall (Z-1314-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Lue recall (Z-0181-06)Terumo Cardiovascular Systems Corp2005-11-23