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FDA 510(k)

BIOTEQ Drainage Catheter BT-PDS-series

K-Number: K210419 · 2022-04-13

Decision Date2022-04-13
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOTEQ Drainage Catheter BT-PDS-series is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque Corporation. It received FDA 510(k) clearance on 2022-04-13 under 510(k) number K210419. 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 BT-PDS-series?

BIOTEQ Drainage Catheter BT-PDS-series is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is Bioteque Corporation. The 510(k) number is K210419.

When did BIOTEQ Drainage Catheter BT-PDS-series receive FDA 510(k) clearance?

BIOTEQ Drainage Catheter BT-PDS-series received FDA 510(k) clearance on 2022-04-13, under 510(k) number K210419.

Who is the listed applicant for BIOTEQ Drainage Catheter BT-PDS-series?

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

What is the FDA product code for BIOTEQ Drainage Catheter BT-PDS-series?

The FDA product code for BIOTEQ Drainage Catheter BT-PDS-series is FGE.

Other records listing Bioteque Corporation 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.

Related Devices (Code: FGE)

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.

Official Source

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