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FDA 510(k)

CARDIO-BAND

K-Number: K813566 · 1982-02-22

ApplicantCardio-Band, Inc.
Decision Date1982-02-22
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CARDIO-BAND is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Band, Inc.. It received FDA 510(k) clearance on 1982-02-22 under 510(k) number K813566. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO-BAND?

CARDIO-BAND is a medical device that received FDA 510(k) clearance on 1982-02-22. The listed applicant is Cardio-Band, Inc.. The 510(k) number is K813566.

When did CARDIO-BAND receive FDA 510(k) clearance?

CARDIO-BAND received FDA 510(k) clearance on 1982-02-22, under 510(k) number K813566.

Who is the listed applicant for CARDIO-BAND?

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

What is the FDA product code for CARDIO-BAND?

The FDA product code for CARDIO-BAND is LDQ.

Related Clinical Trials

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Related Devices (Code: LDQ)

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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