LKG · Class II · 21 CFR 882.5550

FDA Product Code LKG: Port & Catheter, Implanted, Subcutaneous, Intraventricular

Leading manufacturers include Pudenz-Schulte Medical Research Corp., Pharmacia Deltec, Inc. and Holter-Hausner Intl..

8
Total
8
Cleared
107d
Avg days
1983
Since

FDA 510(k) Cleared Port & Catheter, Implanted, Subcutaneous, Intraventricular Devices (Product Code LKG)

8 devices
1–8 of 8
Cleared May 09, 1995
CORDIS CSF RESERVOIR
K950315
Cordis Corp.
General Hospital · 103d
Cleared May 20, 1988
PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.
K881493
Pharmacia Deltec, Inc.
General Hospital · 42d
Cleared May 20, 1988
PORT-A-CATH PORTAL INTRODUCER FORCEPS
K881690
Pharmacia Deltec, Inc.
General Hospital · 31d
Cleared Feb 11, 1988
P-S MEDICAL VENTRICULAR ACCESS PORT
K874468
Pudenz-Schulte Medical Research Corp.
General Hospital · 101d
Cleared Feb 11, 1988
CSF-VENTRICULOSTOMY RESERVOIR
K874498
Pudenz-Schulte Medical Research Corp.
General Hospital · 101d
Cleared May 25, 1984
P-S MEDICAL CSF ACCESS DEV 15MM/25MM
K833822
Pudenz-Schulte Medical Research Corp.
General Hospital · 205d
Cleared Mar 06, 1984
HH SUBCUTANEOUS ACCESS PORT
K833672
Holter-Hausner Intl.
General Hospital · 140d

About Product Code LKG - Regulatory Context