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FDA 510(k)

VENOFIX SCALP VEIN SET

K-Number: K813083 · 1981-11-16

ApplicantBurron Medical Products, Inc.
Decision Date1981-11-16
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VENOFIX SCALP VEIN SET is the device name listed in this FDA 510(k) record. The listed applicant is Burron Medical Products, Inc.. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K813083. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENOFIX SCALP VEIN SET?

VENOFIX SCALP VEIN SET is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Burron Medical Products, Inc.. The 510(k) number is K813083.

When did VENOFIX SCALP VEIN SET receive FDA 510(k) clearance?

VENOFIX SCALP VEIN SET received FDA 510(k) clearance on 1981-11-16, under 510(k) number K813083.

Who is the listed applicant for VENOFIX SCALP VEIN SET?

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

What is the FDA product code for VENOFIX SCALP VEIN SET?

The FDA product code for VENOFIX SCALP VEIN SET is FPA.

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Other records listing Burron Medical Products, Inc. as applicant

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Related Devices (Code: FPA)

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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