Medical Device Manufacturer · US , Levittown , PA

Bioteque Corp. - FDA 510(k) Cleared Devices

11 submissions · 10 cleared · Since 1992

11

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bioteque Corp. Gastroenterology & Urology ✕

5 devices

1-5 of 5

Cleared Feb 14, 2005

BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY...

Gastroenterology & Urology · 430d

Cleared Dec 30, 2004

BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET

Gastroenterology & Urology · 454d

Cleared Jul 09, 2002

BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK

Gastroenterology & Urology · 246d

Cleared Feb 09, 2000

BIOTEQUE HEMODIALYSIS BLOOD TUBING SET

Gastroenterology & Urology · 162d

Cleared Dec 17, 1999

BIOTEQUE A.V. FISTULA NEEDLE SET

Gastroenterology & Urology · 88d