3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100

Pacemaker Lead Adaptor

POSSIS MEDICAL, INC.

The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for 3.2-5mm Unipolar Lead Upsizing Kit, Model Ak 100.

Pre-market Notification Details

Device IDK900605
510k NumberK900605
Device Name:3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100
ClassificationPacemaker Lead Adaptor
Applicant POSSIS MEDICAL, INC. 8325 10TH AVENUE NORTH Minneapolis,  MN  55427
ContactRobert J Scott
CorrespondentRobert J Scott
POSSIS MEDICAL, INC. 8325 10TH AVENUE NORTH Minneapolis,  MN  55427
Product CodeDTD  
CFR Regulation Number870.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-08
Decision Date1990-03-06

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