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FDA 510(k)

GENESISCS COMPONENT CONCENTRATING SYSTEM

K-Number: K070666 · 2007-06-20

ApplicantPerfusion Partners & Assoc., Inc.
Decision Date2007-06-20
Product CodeJQC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENESISCS COMPONENT CONCENTRATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Perfusion Partners & Assoc., Inc.. It received FDA 510(k) clearance on 2007-06-20 under 510(k) number K070666. The device is classified under product code JQC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESISCS COMPONENT CONCENTRATING SYSTEM?

GENESISCS COMPONENT CONCENTRATING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-20. The listed applicant is Perfusion Partners & Assoc., Inc.. The 510(k) number is K070666.

When did GENESISCS COMPONENT CONCENTRATING SYSTEM receive FDA 510(k) clearance?

GENESISCS COMPONENT CONCENTRATING SYSTEM received FDA 510(k) clearance on 2007-06-20, under 510(k) number K070666.

Who is the listed applicant for GENESISCS COMPONENT CONCENTRATING SYSTEM?

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

What is the FDA product code for GENESISCS COMPONENT CONCENTRATING SYSTEM?

The FDA product code for GENESISCS COMPONENT CONCENTRATING SYSTEM is JQC.

Related Clinical Trials

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.

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Other records listing Perfusion Partners & Assoc., Inc. as applicant

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.

K024080SECQUIRE CELL SEPARATOR

Related Devices (Code: JQC)

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.

K183205PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL SystemEmcyte CorporationK103340SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEMHarvest Technologies, Corp.K081345AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)Thermogenesis Corp.K071934MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KITBiomet Manufacturing CorpK052925SMARTPREP2 CENTRIFUGE SYSTEMHarvest Technologies, Corp.K042473COBE ANGEL WHOLE BLOOD SEPARATION SYSTEMCobe Cardiovascular, Inc.

Official Source

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

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