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FDA 510(k)

INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES

K-Number: K131446 · 2013-10-28

ApplicantIntegra LifeSciences Corporation
Decision Date2013-10-28
Product CodeDQR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2013-10-28 under 510(k) number K131446. The device is classified under product code DQR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES?

INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES is a medical device that received FDA 510(k) clearance on 2013-10-28. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K131446.

When did INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES receive FDA 510(k) clearance?

INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES received FDA 510(k) clearance on 2013-10-28, under 510(k) number K131446.

Who is the listed applicant for INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES?

The FDA product code for INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES is DQR.

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Related Devices (Code: DQR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K07355918 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA IIEdwards Lifesciences Research MedicalK051655ANGIODYNAMICS, INC., MICRO ACCESS KITSAngioDynamics, Inc.K030398CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221Cardiacassist, Inc.K960098RMI INTERNAL MAMMARY ARTERY CANNULAResearch Medical, Inc.K902674DATASCOPE ARTERIAL CANNULA W/ACCESS PORTDatascope Corp.K894784MODIFIED SHILEY FEMORAL VENOUS CANNULAShiley, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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