Company ยท US
Bioteque Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2025. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 4 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 2 |
| FPA | Set, Administration, Intravascular | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 |
| FAD | Stent, Ureteral | 1 |
| FIE | Needle, Fistula | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 2025 | K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G Bioteque Corporation, TW | FGE |
| Apr 13, 2022 | K210419 | BIOTEQ Drainage Catheter BT-PDS-series Bioteque Corporation, TW | FGE |
| Oct 9, 2020 | K200103 | BIOTEQ Drainage Catheter Set (One Step Type) Bioteque Corporation, TW | FGE |
| Jul 22, 2016 | K150932 | Sheath Introducer Bioteque Corp., TW | DRE |
| Sep 9, 2011 | K102633 | BIOTEQ ANGIOGRAPHIC CATHETER Bioteque Corp. | DQO |
| Feb 14, 2005 | K033862 | BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK Bioteque Corp., TW | FGE |
| Dec 30, 2004 | K033210 | BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET Bioteque Corp. | FAD |
| Mar 22, 2004 | K032292 | BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX Bioteque Corp. | FOZ |
| Jul 9, 2002 | K013634 | BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK Bioteque Corp. | FJK |
| Sep 14, 2001 | K012526 | BIOTEQUE SCALP VEIN SET Bioteque Corp. | FPA |
| Dec 22, 2000 | K002449 | BIOTEQ I.V. (INTRAVENOUS) SET Bioteque Corp. | FPA |
| Feb 9, 2000 | K992930 | BIOTEQUE HEMODIALYSIS BLOOD TUBING SET Bioteque Corp. | FJK |
| Dec 17, 1999 | K993118 | BIOTEQUE A.V. FISTULA NEEDLE SET Bioteque Corp. | FIE |
| Nov 4, 1992 | K915491 | CURELLE Bioteque Corp. | HHK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||