GYK · Class I · 21 CFR 882.4545

FDA Product Code GYK: Instrument, Shunt System Implantation

Leading manufacturers include Holter-Hausner Intl., Cordis Corp. and American V. Mueller.

13
Total
13
Cleared
58d
Avg days
1977
Since

FDA 510(k) Cleared Instrument, Shunt System Implantation Devices (Product Code GYK)

13 devices
1–13 of 13
Cleared Oct 11, 1996
REIGEL TUNNELING DEVICE
K962761
Cook, Inc.
Neurology · 87d
Cleared Nov 19, 1993
V/P AND L/P CATHETER PASSERS
K934391
Radionics, Inc.
Neurology · 71d
Cleared Sep 10, 1993
PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
K930606
Pudenz-Schulte Medical Research Corp.
Neurology · 217d
Cleared Aug 23, 1993
CORDIS TUNNELER
K932273
Cordis Corp.
Neurology · 102d
Cleared Oct 31, 1989
HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE
K895868
Baxter Healthcare Corp
Neurology · 27d
Cleared Sep 30, 1988
PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER
K883607
Codman & Shurtleff, Inc.
Neurology · 38d
Cleared Dec 18, 1987
HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
K873771
American V. Mueller
Neurology · 93d
Cleared Jan 13, 1987
H-H SUBGALEAL TROCAR
K865075
Holter-Hausner Intl.
Neurology · 15d
Cleared Sep 18, 1985
H-H CATHETER PASSERS(TACL DESIGN
K853370
Holter-Hausner Intl.
Neurology · 37d
Cleared Sep 06, 1985
H-H SHUNT INTRODUCER
K853368
Holter-Hausner Intl.
Neurology · 25d
Cleared May 14, 1984
H-H SHUNT PASSERS
K841553
Holter-Hausner Intl.
Neurology · 28d
Cleared Dec 31, 1979
H-H SHUNT INTRODUCER
K792639
Holter-Hausner Intl.
Neurology · 11d
Cleared Aug 16, 1977
PERITONEAL INTRODUCER & SHEATH
K771529
Cordis Corp.
Neurology · 8d

About Product Code GYK - Regulatory Context