GYK

Product Code: GYK


Products Classified as GYK

3679Instrument, Shunt System ImplantationShunt System Implantation Instrument.

Total Product Life Cycle (TPLC) Devices

3679Instrument, Shunt System ImplantationShunt System Implantation Instrument.

FDA Consensus Standards

Instrument, Shunt System Implantation [33268]21 CFR §882.4545 🔎
Instrument, Shunt System Implantation [32111]21 CFR §882.4545 🔎

Pre-market Notifications for GYK

K962761REIGEL TUNNELING DEVICECOOK, INC.
K934391V/P AND L/P CATHETER PASSERSRADIONICS, INC.
K932273CORDIS TUNNELERCORDIS CORP.
K930606PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSERPUDENZ-SCHULTE MEDICAL RESEARCH CORP.
K895868HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEBAXTER HEALTHCARE CORP.
K883607PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETERCodman & Shurtleff, Inc.
K873771HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTROAMERICAN V. MUELLER
K865075H-H SUBGALEAL TROCARHOLTER-HAUSNER INTL.
K853368H-H SHUNT INTRODUCERHOLTER-HAUSNER INTL.
K853370H-H CATHETER PASSERS(TACL DESIGNHOLTER-HAUSNER INTL.
K841553H-H SHUNT PASSERSHOLTER-HAUSNER INTL.
K792639H-H SHUNT INTRODUCERHOLTER-HAUSNER INTL.
K771529PERITONEAL INTRODUCER & SHEATHCORDIS CORP.

Global Unique Device Identification Database

00866614000177Instrument, Shunt System Implantation
00866614000160Instrument, Shunt System Implantation
00866614000153Instrument, Shunt System Implantation
00866614000146Instrument, Shunt System Implantation
00866614000139Instrument, Shunt System Implantation
00866614000122Instrument, Shunt System Implantation
20886704042744Instrument, shunt system implantation
20886704042737Instrument, shunt system implantation
20886704042720Instrument, shunt system implantation
00381780521412Instrument, shunt system implantation
00381780521405Instrument, shunt system implantation
00381780521399Instrument, shunt system implantation
00382830055420Instrument, Shunt System Implantation
00382830057431Instrument, Shunt System Implantation
00382830057509Instrument, Shunt System Implantation

Maude Adverse Events

CATHETER PASSER, DISPOSABLE, 38 CMMEDTRONIC NEUROSURGERY2017-03-24
PERITONEAL INTRODUCER SHEATHS 70CMINTEGRA NEUROSCICENCS IMPLANTS SA2016-09-29
CARDIO THORACIC UNKNOWNCOVIDIEN2016-02-01
CATHETER PASSER 60CMMEDTRONIC2016-01-19
HOFF PASS-LONGCODMAN & SHURTLEFF2014-05-15
CODMAN BACTISEAL VENTRICULAR CATHETERCODMAN & SHURTLEFF, INC.2014-05-12
SHUNT TUNNELERINTEGRA NEUROSCIENCES IMPLANTS S.A.2013-12-20
SHUNT TUNNELERINTEGRA NEUROSCIENCES IMPLANTS SA2012-08-14
SHUNT TUNNELERINTEGRA NEUROSCIENCES IMPLANTS SA2012-08-14
POLARIS ADJUSTABLE PRESSURE VALVE SHUNTSOPHYSA2005-12-30
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