Medical Device Manufacturer · US , Mansfield , MA

The Kendall Company - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2001

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - The Kendall Company Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared May 13, 2003

MAHURKAR OPLUS CATHETER, MODEL 13.5 FR

Gastroenterology & Urology · 112d

Cleared Apr 10, 2002

MAHURKAR TRIPLE LUMEN CATHETER, 12 FR

Gastroenterology & Urology · 90d

Cleared Apr 09, 2001

TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS

Gastroenterology & Urology · 203d

Cleared Mar 28, 2001

KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER

Gastroenterology & Urology · 191d