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FDA 510(k)

CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS

K-Number: K960755 · 1996-05-23

ApplicantMedtronic Cardiac Surgery, Medtronic, Inc.
Decision Date1996-05-23
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Cardiac Surgery, Medtronic, Inc.. It received FDA 510(k) clearance on 1996-05-23 under 510(k) number K960755. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS?

CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS is a medical device that received FDA 510(k) clearance on 1996-05-23. The listed applicant is Medtronic Cardiac Surgery, Medtronic, Inc.. The 510(k) number is K960755.

When did CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS receive FDA 510(k) clearance?

CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS received FDA 510(k) clearance on 1996-05-23, under 510(k) number K960755.

Who is the listed applicant for CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS?

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

What is the FDA product code for CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS?

The FDA product code for CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS is DQX.

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Other records listing Medtronic Cardiac Surgery, Medtronic, 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.

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Official Source

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

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