Atlas FDA

TENDERFLOW PERIATRIC ARTERIAL CANNULA

FDA 510(k) clearance K063618 · decided 2007-03-13

Clearance details

K-number
K063618
Device name
TENDERFLOW PERIATRIC ARTERIAL CANNULA
Applicant
Terumo Cardiovascular Systems Corp.
Decision
Substantially Equivalent
Date received
2006-12-05
Decision date
2007-03-13
Days to decision
98 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
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented conne recall (Z-0630-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented co recall (Z-0631-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented conne recall (Z-0632-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented co recall (Z-0633-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented conn recall (Z-0634-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented recall (Z-0635-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch vented con recall (Z-0636-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch non-vented recall (Z-0637-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 4.7 mm (14Fr) OD, with 1/4 inch vented conn recall (Z-0638-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented recall (Z-0639-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented con recall (Z-0640-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented recall (Z-0641-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented conne recall (Z-0874-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented co recall (Z-0875-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented conne recall (Z-0876-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented co recall (Z-0877-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented conn recall (Z-0878-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented recall (Z-0879-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch vented con recall (Z-0880-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch non-vented recall (Z-0881-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 4.7 mm (14Fr) OD, with 1/4 inch vented conn recall (Z-0882-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented recall (Z-0883-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented con recall (Z-0884-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented recall (Z-0885-2007)Terumo Cardiovascular Systems Corp2007-07-10