FIH · Class II · 21 CFR 876.5820

FDA Product Code FIH: Pump, Infusion Or Syringe, Extra-luminal

Leading manufacturers include B&B Medical Assoc., Inc., L H M Ent., Inc. and Pharmacia Deltec, Inc..

5
Total
5
Cleared
298d
Avg days
1988
Since

FDA 510(k) Cleared Pump, Infusion Or Syringe, Extra-luminal Devices (Product Code FIH)

5 devices
1–5 of 5
Cleared Mar 21, 1995
PERCUPUMP II
K932055
E-Z-Em, Inc.
Radiology · 692d
Cleared Apr 28, 1994
CADD-TPN(TM) AMBULATORY INFUSION SYSTEM
K931113
Pharmacia Deltec, Inc.
Gastroenterology & Urology · 420d
Cleared Apr 28, 1994
VECTOR AMBULATORY DRUG DELIVERY SYSTEM
K935461
Infusion Technology Intl.
Gastroenterology & Urology · 167d
Cleared Feb 15, 1990
SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC
K900439
L H M Ent., Inc.
Gastroenterology & Urology · 17d
Cleared Oct 21, 1988
INTROCULAR FLUID INJECTOR
K881707
B&B Medical Assoc., Inc.
Gastroenterology & Urology · 193d

About Product Code FIH - Regulatory Context