Atlas FDA

X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS

FDA 510(k) clearance K083301 · decided 2008-12-18

Clearance details

K-number
K083301
Device name
X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS
Applicant
Terumo Cardiovascular Systems Corp.
Decision
Substantially Equivalent
Date received
2008-11-10
Decision date
2008-12-18
Days to decision
38 days
Clearance type
Special
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 Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connec recall (Z-2096-2014)Terumo Cardiovascular Systems Corporation2014-07-23
Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/ recall (Z-2097-2014)Terumo Cardiovascular Systems Corporation2014-07-23
Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 recall (Z-0666-2013)Terumo Cardiovascular Systems Corporation2013-01-11
Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5i recall (Z-0667-2013)Terumo Cardiovascular Systems Corporation2013-01-11
Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in ( recall (Z-0668-2013)Terumo Cardiovascular Systems Corporation2013-01-11
Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) recall (Z-0669-2013)Terumo Cardiovascular Systems Corporation2013-01-11
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) recall (Z-0670-2013)Terumo Cardiovascular Systems Corporation2013-01-11
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) recall (Z-0671-2013)Terumo Cardiovascular Systems Corporation2013-01-11
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LO recall (Z-1834-2012)Terumo Cardiovascular Systems Corporation2012-06-20
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