IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS— 510(k) K093419

Substantially Equivalent

Stryker Instruments, Instruments Div.

FDA 510(k) clearance K093419 for IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS, Substantially Equivalent on 2010-03-18. Applicant: Stryker Instruments, Instruments Div..

Clearance details

Applicant: Stryker Instruments, Instruments Div.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2009-11-02
Decision date: 2010-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

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Adverse events under product code NDN

product code NDN

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 →

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