TB SERIES BIPOLAR PACING LEADS

Electrode, Pacemaker, Temporary

OSCOR MEDICAL CORP.

The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Tb Series Bipolar Pacing Leads.

Pre-market Notification Details

Device IDK861403
510k NumberK861403
Device Name:TB SERIES BIPOLAR PACING LEADS
ClassificationElectrode, Pacemaker, Temporary
Applicant OSCOR MEDICAL CORP. 2311 US ALT. 19N. P.O. BOX 459 Palm Harbor,  FL  33563
ContactDe Graad
CorrespondentDe Graad
OSCOR MEDICAL CORP. 2311 US ALT. 19N. P.O. BOX 459 Palm Harbor,  FL  33563
Product CodeLDF  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-15
Decision Date1986-06-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885672001872 K861403 000
00836559009764 K861403 000
00836559009757 K861403 000
00836559009740 K861403 000
00836559009733 K861403 000
00836559009726 K861403 000
00836559009719 K861403 000
00836559009702 K861403 000
00836559009696 K861403 000
00836559009078 K861403 000
00836559009061 K861403 000
00836559009054 K861403 000
00836559009047 K861403 000
00836559009030 K861403 000
00836559009023 K861403 000
00836559007265 K861403 000
00836559009771 K861403 000
00836559009788 K861403 000
00885672001865 K861403 000
00836559009924 K861403 000
00836559009917 K861403 000
00836559009900 K861403 000
00836559009894 K861403 000
00836559009887 K861403 000
00836559009870 K861403 000
00836559009863 K861403 000
00836559009856 K861403 000
00836559009849 K861403 000
00836559009832 K861403 000
00836559009825 K861403 000
00836559009818 K861403 000
00836559009801 K861403 000
00836559009795 K861403 000
00836559007258 K861403 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.