Medical Device Manufacturer · US , Boston , MA

Boston Pacific Medical, Inc. - FDA 510(k) Cleared Devices

11 submissions · 8 cleared · Since 1992

11

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Boston Pacific Medical, Inc. Gastroenterology & Urology ✕

7 devices

1-7 of 7

Cleared Mar 28, 1994

4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS

Gastroenterology & Urology · 276d

Cleared Mar 25, 1994

4 SURE TM ENTERAL FEEDING BAG

Gastroenterology & Urology · 673d

Cleared Feb 14, 1994

4-SURE FEMALE CATHETER

Gastroenterology & Urology · 350d

Cleared Feb 14, 1994

4-SURE NELATON CATHETER

Gastroenterology & Urology · 350d

Cleared Jul 13, 1993

4 SURE TM FEEDING TUBES

Gastroenterology & Urology · 452d

Cleared Jun 17, 1993

4 SURE TM ENEMA BAG SET

Gastroenterology & Urology · 392d

Cleared Jun 10, 1992

4 SURE TM COLOSTOMY POUCH

Gastroenterology & Urology · 20d