FDA 510(k)

BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET

K-Number: K033210 · 2004-12-30

Decision Date2004-12-30

Product CodeFAD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BIOTEQ DOUBLE PIGTAIL URETERAL STENT 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 2004-12-30 under 510(k) number K033210. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET?

BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET is a medical device that received FDA 510(k) clearance on 2004-12-30. The listed applicant is Bioteque Corp.. The 510(k) number is K033210.

When did BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET receive FDA 510(k) clearance?

BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET received FDA 510(k) clearance on 2004-12-30, under 510(k) number K033210.

Who is the listed applicant for BIOTEQ DOUBLE PIGTAIL URETERAL STENT 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 BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET?

The FDA product code for BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET is FAD.

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Other records listing Bioteque Corp. as applicant

K150932Sheath Introducer K102633BIOTEQ ANGIOGRAPHIC CATHETER K033862BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK K032292BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX K013634BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK K012526BIOTEQUE SCALP VEIN SET

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Related Devices (Code: FAD)

K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd.K243039Ureteral Stents (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd.K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent SetBoston Scientific Corporation K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company

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.