Medical Device Manufacturer · US , Plymouth , MN

Ev3, Inc. - FDA 510(k) Cleared Devices

35 submissions · 26 cleared · Since 2003

Recent clearances: NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER, NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER, RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER

35
Total
26
Cleared
0
Denied

Ev3, Inc. has 26 FDA 510(k) cleared cardiovascular devices. Based in Plymouth, US.

Historical record: 26 cleared submissions from 2003 to 2014.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant. 2 devices have linked clinical trials registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Ev3, Inc.

35 devices
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