Reprocessed Electrophysiology Catheter

Catheter, Recording, Electrode, Reprocessed

INNOVATIVE HEALTH, LLC

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

Pre-market Notification Details

• Device ID: K153153
• 510k Number: K153153
• Device Name: Reprocessed Electrophysiology Catheter
• Classification: Catheter, Recording, Electrode, Reprocessed
• Applicant: INNOVATIVE HEALTH, LLC 1435 NORTH HAYDEN ROAD, SUITE 100 Scottsdale, AZ 85257
• Contact: Rafal Chudzik
• Correspondent: Rafal Chudzik; INNOVATIVE HEALTH, LLC 1435 NORTH HAYDEN ROAD, SUITE 100 Scottsdale, AZ 85257
• Product Code: NLH
• CFR Regulation Number: 870.1220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-11-02
• Decision Date: 2016-03-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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