Atlas FDA

FLEXIBLE ARTERIAL CANNULAE

FDA 510(k) clearance K771499 · decided 1977-08-16

Clearance details

K-number
K771499
Device name
FLEXIBLE ARTERIAL CANNULAE
Applicant
3M Health Care, Sarns
Decision
Substantially Equivalent
Date received
1977-08-05
Decision date
1977-08-16
Days to decision
11 days
Clearance type
Traditional
Product code
DWF
Device class
2
Regulation number
870.4210
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aort recall (Z-2095-2014)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 FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" ( recall (Z-1835-2012)Terumo Cardiovascular Systems Corporation2012-06-20
SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" ( recall (Z-1836-2012)Terumo Cardiovascular Systems Corporation2012-06-20
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 recall (Z-1837-2012)Terumo Cardiovascular Systems Corporation2012-06-20
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (2 recall (Z-1838-2012)Terumo Cardiovascular Systems Corporation2012-06-20
Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, s recall (Z-0200-06)Terumo Cardiovascular Systems Corp2005-11-26