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FDA 510(k)

CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221

K-Number: K030398 · 2003-05-23

ApplicantCardiacassist, Inc.
Decision Date2003-05-23
Product CodeDQR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2003-05-23 under 510(k) number K030398. 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 CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221?

CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 is a medical device that received FDA 510(k) clearance on 2003-05-23. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K030398.

When did CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 receive FDA 510(k) clearance?

CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 received FDA 510(k) clearance on 2003-05-23, under 510(k) number K030398.

Who is the listed applicant for CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221?

The FDA 510(k) record lists Cardiacassist, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221?

The FDA product code for CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 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.

K131446INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLESIntegra LifeSciences CorporationK07355918 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA IIEdwards Lifesciences Research MedicalK051655ANGIODYNAMICS, INC., MICRO ACCESS KITSAngioDynamics, 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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