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FDA 510(k)

BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX

K-Number: K032292 · 2004-03-22

ApplicantBioteque Corp.
Decision Date2004-03-22
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque Corp.. It received FDA 510(k) clearance on 2004-03-22 under 510(k) number K032292. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX?

BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX is a medical device that received FDA 510(k) clearance on 2004-03-22. The listed applicant is Bioteque Corp.. The 510(k) number is K032292.

When did BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX receive FDA 510(k) clearance?

BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX received FDA 510(k) clearance on 2004-03-22, under 510(k) number K032292.

Who is the listed applicant for BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX?

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

What is the FDA product code for BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX?

The FDA product code for BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX is FOZ.

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Other records listing Bioteque Corp. as applicant

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Related Devices (Code: FOZ)

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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