BIOTEQ Drainage Catheter BT-PDS-series
K-Number: K210419 · 2022-04-13
ApplicantBioteque Corporation
Decision Date2022-04-13
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
BIOTEQ Drainage Catheter BT-PDS-series is a medical device manufactured by Bioteque Corporation. It received FDA 510(k) clearance on 2022-04-13 under approval 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. It is manufactured by Bioteque Corporation. The 510(k) number is K210419.
When was BIOTEQ Drainage Catheter BT-PDS-series approved by the FDA?
BIOTEQ Drainage Catheter BT-PDS-series received FDA 510(k) clearance on 2022-04-13, under approval number K210419.
What company makes BIOTEQ Drainage Catheter BT-PDS-series?
BIOTEQ Drainage Catheter BT-PDS-series is manufactured by Bioteque Corporation.
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.
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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.