NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Nc Euphora Rapid Exchange Balloon Dilatation Catheter.

Pre-market Notification Details

• Device ID: K141090
• 510k Number: K141090
• Device Name: NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER
• Classification: Catheters, Transluminal Coronary Angioplasty, Percutaneous
• Applicant: MEDTRONIC INC. PARKMORE BUSINESS PARK WEST Galway, IE Ireland
• Contact: John Kilmartin
• Correspondent: John Kilmartin; MEDTRONIC INC. PARKMORE BUSINESS PARK WEST Galway, IE Ireland
• Product Code: LOX
• CFR Regulation Number: 870.5100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-04-28
• Decision Date: 2014-08-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169395770	K141090	000
00643169395930	K141090	000
00643169395947	K141090	000
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