IVAS BALLOON CATHETER— 510(k) K113154

Clearance details

Applicant

Stryker Corporation

Product code

Code NDN

Device class

Class 2

Regulation

21 CFR 888.3027

Advisory panel

Orthopedic

Date received

2011-10-26

Decision date

2012-01-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Kalamazoo, MI, US

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Death

24

Injury

407

Malfunction

1,975

Total

2,406

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 →