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FDA 510(k)

LEATHER VALVULOTOME

K-Number: K821569 · 1982-05-27

ApplicantAmerican V. Mueller
Decision Date1982-05-27
Product CodeDWS
Advisory CommitteeCV
DecisionUnknown

Device Summary

LEATHER VALVULOTOME is the device name listed in this FDA 510(k) record. The listed applicant is American V. Mueller. It received FDA 510(k) clearance on 1982-05-27 under 510(k) number K821569. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the LEATHER VALVULOTOME?

LEATHER VALVULOTOME is a medical device that received FDA 510(k) clearance on 1982-05-27. The listed applicant is American V. Mueller. The 510(k) number is K821569.

When did LEATHER VALVULOTOME receive FDA 510(k) clearance?

LEATHER VALVULOTOME received FDA 510(k) clearance on 1982-05-27, under 510(k) number K821569.

Who is the listed applicant for LEATHER VALVULOTOME?

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

What is the FDA product code for LEATHER VALVULOTOME?

The FDA product code for LEATHER VALVULOTOME is DWS.

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Other records listing American V. Mueller 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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Related Devices (Code: DWS)

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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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