BIPOLAR TEMP. PACING CATHETER W/STYLETET

Electrode, Pacemaker, Temporary

ZIEHM INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Bipolar Temp. Pacing Catheter W/styletet.

Pre-market Notification Details

Device IDK822002
510k NumberK822002
Device Name:BIPOLAR TEMP. PACING CATHETER W/STYLETET
ClassificationElectrode, Pacemaker, Temporary
Applicant ZIEHM INTERNATIONAL, INC. 906-A COMMERCE RD. Annapolis,  MD  21401
Product CodeLDF  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-07-08
Decision Date1982-10-15

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