MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD

Permanent Pacemaker Electrode

INTERMEDICS, INC.

The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Model 438-01 Cardifix Implantable Pacing Lead.

Pre-market Notification Details

Device IDK862052
510k NumberK862052
Device Name:MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD
ClassificationPermanent Pacemaker Electrode
Applicant INTERMEDICS, INC. P.O. BOX 617 Freeport,  TX  77541 -0617
ContactLisa S Jones
CorrespondentLisa S Jones
INTERMEDICS, INC. P.O. BOX 617 Freeport,  TX  77541 -0617
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-29
Decision Date1986-07-03

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