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FDA 510(k)

AFFINITY BLOOD PUMP SYSTEM

K-Number: K964017 · 1997-08-05

ApplicantAvecor Cardiovascular, Inc.
Decision Date1997-08-05
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AFFINITY BLOOD PUMP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Avecor Cardiovascular, Inc.. It received FDA 510(k) clearance on 1997-08-05 under 510(k) number K964017. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFFINITY BLOOD PUMP SYSTEM?

AFFINITY BLOOD PUMP SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-05. The listed applicant is Avecor Cardiovascular, Inc.. The 510(k) number is K964017.

When did AFFINITY BLOOD PUMP SYSTEM receive FDA 510(k) clearance?

AFFINITY BLOOD PUMP SYSTEM received FDA 510(k) clearance on 1997-08-05, under 510(k) number K964017.

Who is the listed applicant for AFFINITY BLOOD PUMP SYSTEM?

The FDA 510(k) record lists Avecor Cardiovascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFFINITY BLOOD PUMP SYSTEM?

The FDA product code for AFFINITY BLOOD PUMP SYSTEM is DTQ.

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Other records listing Avecor Cardiovascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K973760AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACEK971105MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEMK952532AFFINITY ARTERIAL BLOOD FILTERK940126AVECOR PRE-BYPASS FILTERK936003AFFINITY CVRK935717AFFINITY VENOUS RESERVIOR BAG

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Related Devices (Code: DTQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbHK221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationK221373Essenz HLMLivanova Deutschland, GmbHK210130Stockert S5 SystemLivanova Deutschland, GmbHK202125Century Perfusion SystemCentury Hlm, LLCK190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)Spectrum Medical , Ltd.

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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