VICOR, MODEL 410A

Implantable Pacemaker Pulse-generator

TPL-CORDIS, INC.

The following data is part of a premarket notification filed by Tpl-cordis, Inc. with the FDA for Vicor, Model 410a.

Pre-market Notification Details

Device IDK873202
510k NumberK873202
Device Name:VICOR, MODEL 410A
ClassificationImplantable Pacemaker Pulse-generator
Applicant TPL-CORDIS, INC. 40 CRANE HILL RD. Suffield,  CT  06078
ContactWilliam C Nealon
CorrespondentWilliam C Nealon
TPL-CORDIS, INC. 40 CRANE HILL RD. Suffield,  CT  06078
Product CodeDXY  
CFR Regulation Number870.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-13
Decision Date1987-10-15

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