ELM PTA Balloon Dilatation Catheter

Catheter, Angioplasty, Peripheral, Transluminal

O'CONNELL REGULATORY CONSULTANTS, INC.

The following data is part of a premarket notification filed by O'connell Regulatory Consultants, Inc. with the FDA for Elm Pta Balloon Dilatation Catheter.

Pre-market Notification Details

• Device ID: K143561
• 510k Number: K143561
• Device Name: ELM PTA Balloon Dilatation Catheter
• Classification: Catheter, Angioplasty, Peripheral, Transluminal
• Applicant: O'CONNELL REGULATORY CONSULTANTS, INC. 5 TIMBER LANE North Reading, MA 01864
• Contact: Maureen O'connell
• Correspondent: Maureen O'connell; O'CONNELL REGULATORY CONSULTANTS, INC. 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: 2014-12-16
• Decision Date: 2015-05-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391525783369	K143561	000
05391525783352	K143561	000
05391525783345	K143561	000
05391525781198	K143561	000
05391525781181	K143561	000
05391525781174	K143561	000