IVAS 10MM AND 15MM BALLOON CATHETER— 510(k) K130430

Substantially Equivalent

Stryker Corporation

FDA 510(k) clearance K130430 for IVAS 10MM AND 15MM BALLOON CATHETER, Substantially Equivalent on 2013-05-23. Applicant: Stryker Corporation.

Clearance details

Applicant: Stryker Corporation
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2013-02-20
Decision date: 2013-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Kalamazoo, MI, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.