Atlas FDA

CANNULAE, AORTIC, ARCH, HIGH FLOW

FDA 510(k) clearance K770429 · decided 1977-03-16

Clearance details

K-number
K770429
Device name
CANNULAE, AORTIC, ARCH, HIGH FLOW
Applicant
3M Health Care, Sarns
Decision
Substantially Equivalent
Date received
1977-03-07
Decision date
1977-03-16
Days to decision
9 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 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: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) L recall (Z-1832-2012)Terumo Cardiovascular Systems Corporation2012-06-20
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LO recall (Z-1833-2012)Terumo Cardiovascular Systems Corporation2012-06-20
24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for u recall (Z-1839-2012)Terumo Cardiovascular Systems Corporation2012-06-20
SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in p recall (Z-1840-2012)Terumo Cardiovascular Systems Corporation2012-06-20
CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use i recall (Z-1841-2012)Terumo Cardiovascular Systems Corporation2012-06-20
CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for recall (Z-1842-2012)Terumo Cardiovascular Systems Corporation2012-06-20