PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER

Instrument, Shunt System Implantation

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Peel-away Introducer For Ventricular Catheter.

Pre-market Notification Details

Device IDK883607
510k NumberK883607
Device Name:PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER
ClassificationInstrument, Shunt System Implantation
Applicant Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph,  MA  02368 -1794
ContactThomas J Courage
CorrespondentThomas J Courage
Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph,  MA  02368 -1794
Product CodeGYK  
CFR Regulation Number882.4545 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-23
Decision Date1988-09-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20886704042744 K883607 000
20886704042737 K883607 000
20886704042720 K883607 000
00381780521412 K883607 000
00381780521405 K883607 000
00381780521399 K883607 000

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