Atlas FDA

AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014

FDA 510(k) clearance K071253 · decided 2007-07-03

Clearance details

K-number
K071253
Device name
AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2007-05-04
Decision date
2007-07-03
Days to decision
60 days
Clearance type
Traditional
Product code
DTM
Device class
2
Regulation number
870.4260
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylen recall (Z-1966-2013)Medtronic Inc. Cardiac Rhythm Disease Management2013-08-14
Medtronic Affinity Pediatric arterial Filter, Arterial Line Filter for Cardiopulmonary Byp recall (Z-1921-2008)Medtronic Perfusion Systems2008-07-24

PMA approvals by this applicant

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Resolute Onyx (P160043/S088)Medtronic Vascular2025-06-26
Endurant Stent Graft System (P100021/S130)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073)Medtronic Vascular2025-06-12
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