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FDA 510(k)

BIOTEQ Drainage Catheter Set (One Step Type)

K-Number: K200103 · 2020-10-09

ApplicantBioteque Corporation
Decision Date2020-10-09
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOTEQ Drainage Catheter Set (One Step Type) is a medical device manufactured by Bioteque Corporation. It received FDA 510(k) clearance on 2020-10-09 under approval number K200103. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTEQ Drainage Catheter Set (One Step Type)?

BIOTEQ Drainage Catheter Set (One Step Type) is a medical device that received FDA 510(k) clearance on 2020-10-09. It is manufactured by Bioteque Corporation. The 510(k) number is K200103.

When was BIOTEQ Drainage Catheter Set (One Step Type) approved by the FDA?

BIOTEQ Drainage Catheter Set (One Step Type) received FDA 510(k) clearance on 2020-10-09, under approval number K200103.

What company makes BIOTEQ Drainage Catheter Set (One Step Type)?

BIOTEQ Drainage Catheter Set (One Step Type) is manufactured by Bioteque Corporation.

What is the FDA product code for BIOTEQ Drainage Catheter Set (One Step Type)?

The FDA product code for BIOTEQ Drainage Catheter Set (One Step Type) is FGE.

Related Clinical Trials

NCT04322136 AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion COMPLETED

Other Devices by Bioteque Corporation

K210419BIOTEQ Drainage Catheter BT-PDS-series K251019BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G

Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

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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