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FDA 510(k)

AMERICAN HEYER-SCHULTE LOW PROFILE VALVE

K-Number: K802586 · 1980-12-18

ApplicantAmerican Heyer Schulte
Decision Date1980-12-18
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AMERICAN HEYER-SCHULTE LOW PROFILE VALVE is the device name listed in this FDA 510(k) record. The listed applicant is American Heyer Schulte. It received FDA 510(k) clearance on 1980-12-18 under 510(k) number K802586. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN HEYER-SCHULTE LOW PROFILE VALVE?

AMERICAN HEYER-SCHULTE LOW PROFILE VALVE is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is American Heyer Schulte. The 510(k) number is K802586.

When did AMERICAN HEYER-SCHULTE LOW PROFILE VALVE receive FDA 510(k) clearance?

AMERICAN HEYER-SCHULTE LOW PROFILE VALVE received FDA 510(k) clearance on 1980-12-18, under 510(k) number K802586.

Who is the listed applicant for AMERICAN HEYER-SCHULTE LOW PROFILE VALVE?

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

What is the FDA product code for AMERICAN HEYER-SCHULTE LOW PROFILE VALVE?

The FDA product code for AMERICAN HEYER-SCHULTE LOW PROFILE VALVE is JXG.

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Other records listing American Heyer Schulte 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.

K840172VENTRAL WALL DEFECT REDUCT SILOK834593ONE-PIECE SHUNTK833502RADOVAN SUBCUTANEOUS TISSUE EXPANDERK833698AMER. V. MUELLER SURG. STAPLES ILAK833704AMER. V. MUELLER SURGICALSTAPLES-CARTRK832738HEYER-SCHULTE AFTERLOADING CATHETER

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Related Devices (Code: JXG)

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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