INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES— 510(k) K131446

Substantially Equivalent

Integra LifeSciences Corporation

FDA 510(k) clearance K131446 for INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES, Substantially Equivalent on 2013-10-28. Applicant: Integra LifeSciences Corporation.

Clearance details

Applicant: Integra LifeSciences Corporation
Product code: Code DQR
Advisory panel: Cardiovascular
Date received: 2013-05-20
Decision date: 2013-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQR

product code DQR

Death: 2
Total: 2

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.