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FDA 510(k)

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

K-Number: K071253 · 2007-07-03

ApplicantMedtronic Vascular
Decision Date2007-07-03
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2007-07-03 under 510(k) number K071253. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014?

AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 is a medical device that received FDA 510(k) clearance on 2007-07-03. The listed applicant is Medtronic Vascular. The 510(k) number is K071253.

When did AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 receive FDA 510(k) clearance?

AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 received FDA 510(k) clearance on 2007-07-03, under 510(k) number K071253.

Who is the listed applicant for AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014?

The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014?

The FDA product code for AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 is DTM.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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