FDA.reportPublic FDA data

SYNAPTIC MEDICAL CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30134007083013400708SYNAPTIC MEDICAL CORPORATION1Y2026-01-011959 Kellogg Ave Carlsbad CA US 92008

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2055481656326708K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)DRC2024-07-26
2055481094488765K233900Nordica PV Cryo Mapping CatheterDRF2024-09-06
2055481186528084K233708NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)DYB2024-02-16
2055481331563185K203793RithmID-SD Steerable Diagnostic Electrophysiology CatheterDRF2022-02-14
2055481240664438K151936Steerable Intracardiac Catheter Introducer Kit and Transseptal NeedleDYB2015-12-04
2055481723822742K133028RITHM ID ELECTROPHYSIOLOGY CATHETERDRF2014-03-04
2055481006920732K132943INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLEDRC2014-08-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DRF32024-09-06
DRC22024-07-26
DYB22024-02-16

PMN#