Medical Device Manufacturer · US , Boston , MA

Boston Pacific Medical, Inc.

11 submissions · 8 cleared · Since 1992
11
Total
8
Cleared
0
Denied

Boston Pacific Medical, Inc. — FDA 510(k) Submissions

Boston Pacific Medical, Inc. has submitted 11 FDA 510(k) premarket notifications since 1992, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Straight, Pouch, Colostomy, Tube, Feeding, Catheter, Conduction, Anesthetic, Catheter, Urological . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS
K933109 · KOD Catheter, Urological · Gastroenterology & Urology
Mar 1994 276d
4 SURE TM ENTERAL FEEDING BAG
K922402 · FPD Tube, Feeding · Gastroenterology & Urology
Mar 1994 673d
4-SURE FEMALE CATHETER
K931047 · EZD Catheter, Straight · Gastroenterology & Urology
Feb 1994 350d
4-SURE NELATON CATHETER
K931048 · EZD Catheter, Straight · Gastroenterology & Urology
Feb 1994 350d
4 SURE TM RECTAL TUBE
K921852 · KMO Binder, Elastic · General Hospital
Oct 1993 539d
4 SURE TM FEEDING TUBES
K921853 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Jul 1993 452d
4 SURE TM SUCTION CATHETERS & KITS
K921851 · BSY Catheters, Suction,... · Anesthesiology
Jul 1993 446d
4 SURE TM ENEMA BAG SET
K922398 · FCE Enema Kit · Gastroenterology & Urology
Jun 1993 392d
4 SURE TM NASAL OXYGEN CANNULA
K922397 · CAT Cannula, Nasal, Oxygen · Anesthesiology
Mar 1993 301d
4 SURE TM ANESTHESIA EXTENSION SET
K924995 · BSO Catheter, Conduction,... · Anesthesiology
Dec 1992 90d
4 SURE TM COLOSTOMY POUCH
K922401 · EZQ Pouch, Colostomy · Gastroenterology & Urology
Jun 1992 20d
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