014 Hydrophilic Coated PTA Balloon Dilatation Catheter

Catheter, Angioplasty, Peripheral, Transluminal

Creagh Medical

The following data is part of a premarket notification filed by Creagh Medical with the FDA for 014 Hydrophilic Coated Pta Balloon Dilatation Catheter.

Pre-market Notification Details

• Device ID: K171251
• 510k Number: K171251
• Device Name: 014 Hydrophilic Coated PTA Balloon Dilatation Catheter
• Classification: Catheter, Angioplasty, Peripheral, Transluminal
• Applicant: Creagh Medical IDA Business Park Ballinasloe, IE H53 K8p4
• Contact: Shane Costello
• Correspondent: Shawn Fuller; Surmodics 9924 West 74th Street Eden Prairie, MN 55344
• Product Code: LIT
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-28
• Decision Date: 2017-09-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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05391525784571	K171251	000
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