HEPARIN COATED LUMINAL PACING CATHETER

Catheter, Intravascular, Diagnostic

SPECTRAMED, INC.

The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Heparin Coated Luminal Pacing Catheter.

Pre-market Notification Details

Device IDK875337
510k NumberK875337
Device Name:HEPARIN COATED LUMINAL PACING CATHETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
ContactRobert L Leavitt
CorrespondentRobert L Leavitt
SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-30
Decision Date1988-05-25

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