Reprocessed BRK Transseptal Needle

Trocar, Reprocessed

Innovative Health, LLC.

The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Brk Transseptal Needle.

Pre-market Notification Details

Device IDK192998
510k NumberK192998
Device Name:Reprocessed BRK Transseptal Needle
ClassificationTrocar, Reprocessed
Applicant Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale,  AZ  85257
ContactAmanda Babcock
CorrespondentAmanda Babcock
Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale,  AZ  85257
Product CodeNMK  
CFR Regulation Number870.1390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-28
Decision Date2020-07-22

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