THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT

Occluder, Catheter Tip

IDEAS FOR MEDICINE, INC.

The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for The Robicsek - Pruitt Aortic Balloon Occlusion Kit.

Pre-market Notification Details

Device IDK872090
510k NumberK872090
Device Name:THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT
ClassificationOccluder, Catheter Tip
Applicant IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater,  FL  34622
ContactMark R Waddell
CorrespondentMark R Waddell
IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater,  FL  34622
Product CodeDQT  
CFR Regulation Number870.1370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-01
Decision Date1987-10-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840663101528 K872090 000
00840663101511 K872090 000

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