INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES— 510(k) K131446
Substantially EquivalentIntegra 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. Device class: 2.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code DQR
- Device class
- Class 2
- Regulation
- 21 CFR 870.1300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- York, PA, US
Recent devices under product code DQR
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view all- K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
- K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K221835 — CUSA Clarity Ultrasonic Surgical Aspirator System
Adverse events under product code DQR
product code DQR- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . 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.