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FDA 510(k)

BIOTEQUE HEMODIALYSIS BLOOD TUBING SET

K-Number: K992930 · 2000-02-09

ApplicantBioteque Corp.
Decision Date2000-02-09
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOTEQUE HEMODIALYSIS BLOOD TUBING 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 2000-02-09 under 510(k) number K992930. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTEQUE HEMODIALYSIS BLOOD TUBING SET?

BIOTEQUE HEMODIALYSIS BLOOD TUBING SET is a medical device that received FDA 510(k) clearance on 2000-02-09. The listed applicant is Bioteque Corp.. The 510(k) number is K992930.

When did BIOTEQUE HEMODIALYSIS BLOOD TUBING SET receive FDA 510(k) clearance?

BIOTEQUE HEMODIALYSIS BLOOD TUBING SET received FDA 510(k) clearance on 2000-02-09, under 510(k) number K992930.

Who is the listed applicant for BIOTEQUE HEMODIALYSIS BLOOD TUBING 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 HEMODIALYSIS BLOOD TUBING SET?

The FDA product code for BIOTEQUE HEMODIALYSIS BLOOD TUBING SET is FJK.

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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

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Related Devices (Code: FJK)

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.

K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd.K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )Diality, Inc.K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCK210782Tablo CartridgeOutset Medical, Inc.

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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