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FDA 510(k)

QUEST HEART INSULATION PAD

K-Number: K925049 · 1994-02-01

ApplicantQuest Medical, Inc.
Decision Date1994-02-01
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUEST HEART INSULATION PAD is the device name listed in this FDA 510(k) record. The listed applicant is Quest Medical, Inc.. It received FDA 510(k) clearance on 1994-02-01 under 510(k) number K925049. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUEST HEART INSULATION PAD?

QUEST HEART INSULATION PAD is a medical device that received FDA 510(k) clearance on 1994-02-01. The listed applicant is Quest Medical, Inc.. The 510(k) number is K925049.

When did QUEST HEART INSULATION PAD receive FDA 510(k) clearance?

QUEST HEART INSULATION PAD received FDA 510(k) clearance on 1994-02-01, under 510(k) number K925049.

Who is the listed applicant for QUEST HEART INSULATION PAD?

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

What is the FDA product code for QUEST HEART INSULATION PAD?

The FDA product code for QUEST HEART INSULATION PAD is DWF.

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Related Devices (Code: DWF)

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

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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