Advocate PTA Catheter

Catheter, Angioplasty, Peripheral, Transluminal

Merit Medical Systems Inc.

The following data is part of a premarket notification filed by Merit Medical Systems Inc. with the FDA for Advocate Pta Catheter.

Pre-market Notification Details

• Device ID: K173621
• 510k Number: K173621
• Device Name: Advocate PTA Catheter
• Classification: Catheter, Angioplasty, Peripheral, Transluminal
• Applicant: Merit Medical Systems Inc. Parkmore Business Park West Galway, IE
• Contact: Mark Mullaney
• Correspondent: Michael O’sullivan; Merit Medical Systems Inc. Parkmore Business Park West Galway, IE
• Product Code: LIT
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-11-22
• Decision Date: 2017-12-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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