SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON

Catheters, Transluminal Coronary Angioplasty, Percutaneous

MEDTRONIC IRELAND

The following data is part of a premarket notification filed by Medtronic Ireland with the FDA for Sprinter Legend 1.25mm Rx And Sprinter Legend 1.25mm Otw Balloon.

Pre-market Notification Details

• Device ID: K103095
• 510k Number: K103095
• Device Name: SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
• Classification: Catheters, Transluminal Coronary Angioplasty, Percutaneous
• Applicant: MEDTRONIC IRELAND 3576 Unocal Place Santa Rosa, CA 95403
• Contact: Gerardine Finn
• Correspondent: Gerardine Finn; MEDTRONIC IRELAND 3576 Unocal Place Santa Rosa, CA 95403
• Product Code: LOX
• CFR Regulation Number: 870.5100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-10-08
• Decision Date: 2010-10-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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