510(k) Report

Devices descending from K053245

4 later devices reach GP General Purpose Drainage Catheter; Mini-Pig Drainage Catheter; Nephrostomy… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200103BIOTEQ Drainage Catheter Set (One Step Type)Bioteque Corporation20203—
+2K254179Drainage CatheterCanyon Medical, Inc.20260—
+2K251019BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GBioteque Corporation20250—
+2K210419BIOTEQ Drainage Catheter BT-PDS-seriesBioteque Corporation20222—