NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER— 510(k) K141118

Substantially Equivalent

Ev3, Inc.

FDA 510(k) clearance K141118 for NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER, Substantially Equivalent on 2014-07-18. Applicant: Ev3, Inc..

Clearance details

Applicant: Ev3, Inc.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2014-04-30
Decision date: 2014-07-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.