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FDA 510(k)

BIOTEQUE A.V. FISTULA NEEDLE SET

K-Number: K993118 · 1999-12-17

ApplicantBioteque Corp.
Decision Date1999-12-17
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOTEQUE A.V. FISTULA NEEDLE SET is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque Corp.. It received FDA 510(k) clearance on 1999-12-17 under 510(k) number K993118. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTEQUE A.V. FISTULA NEEDLE SET?

BIOTEQUE A.V. FISTULA NEEDLE SET is a medical device that received FDA 510(k) clearance on 1999-12-17. The listed applicant is Bioteque Corp.. The 510(k) number is K993118.

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

BIOTEQUE A.V. FISTULA NEEDLE SET received FDA 510(k) clearance on 1999-12-17, under 510(k) number K993118.

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

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?

The FDA product code for BIOTEQUE A.V. FISTULA NEEDLE SET is FIE.

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Other records listing Bioteque Corp. 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.

K150932Sheath IntroducerK102633BIOTEQ ANGIOGRAPHIC CATHETERK033862BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCKK033210BIOTEQ DOUBLE PIGTAIL URETERAL STENT SETK032292BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEXK013634BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK

View all 11 devices →

Related Devices (Code: FIE)

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.

K253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)Mozarc Medical Us, LLCK251877JMS CAVEO A.V. Fistula Needle SetJMS North America CorporationK213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)Dimesol, Inc.K163025DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K112734APLAN A.V. FISTULA NEEDLE SETAplan Well Enterprise Co., Ltd.

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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