WILLOW/ELM PTA BALLOON DILATATION CATHETER

Catheter, Angioplasty, Peripheral, Transluminal

CREAGH MEDICAL LTD

The following data is part of a premarket notification filed by Creagh Medical Ltd with the FDA for Willow/elm Pta Balloon Dilatation Catheter.

Pre-market Notification Details

• Device ID: K102645
• 510k Number: K102645
• Device Name: WILLOW/ELM PTA BALLOON DILATATION CATHETER
• Classification: Catheter, Angioplasty, Peripheral, Transluminal
• Applicant: CREAGH MEDICAL LTD 5 TIMBER LANE North Reading, MA 01864
• Contact: Maureen O'connell
• Correspondent: Maureen O'connell; CREAGH MEDICAL LTD 5 TIMBER LANE North Reading, MA 01864
• Product Code: LIT
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-09-13
• Decision Date: 2010-12-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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