AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511

Oxygenator, Cardiopulmonary Bypass

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Affinity Nt Hollow Fiber Oxygenator With Plasma Resistant Fiber With Carmeda Bioactive Surface, Model Cb511.

Pre-market Notification Details

Device IDK000430
510k NumberK000430
Device Name:AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant MEDTRONIC VASCULAR 4633 EAST LA PALMA AVE. Anaheim,  CA  92807
ContactDebra Kridner
CorrespondentDebra Kridner
MEDTRONIC VASCULAR 4633 EAST LA PALMA AVE. Anaheim,  CA  92807
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-09
Decision Date2000-02-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994529101 K000430 000
20613994529095 K000430 000
00643169767805 K000430 000
20681490008574 K000430 000
20721902333884 K000430 000

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