018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter— 510(k) K180007

Clearance details

Applicant

Creagh Medical, Ltd.

Product code

Code LIT

Device class

Class 2

Regulation

21 CFR 870.1250

Advisory panel

Cardiovascular

Date received

2018-01-02

Decision date

2018-04-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ballinasloe, IE

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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 →