Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SMARTPREP2 CENTRIFUGE SYSTEM

K-Number: K052925 · 2006-01-04

ApplicantHarvest Technologies, Corp.
Decision Date2006-01-04
Product CodeJQC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMARTPREP2 CENTRIFUGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Harvest Technologies, Corp.. It received FDA 510(k) clearance on 2006-01-04 under 510(k) number K052925. 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 SMARTPREP2 CENTRIFUGE SYSTEM?

SMARTPREP2 CENTRIFUGE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-01-04. The listed applicant is Harvest Technologies, Corp.. The 510(k) number is K052925.

When did SMARTPREP2 CENTRIFUGE SYSTEM receive FDA 510(k) clearance?

SMARTPREP2 CENTRIFUGE SYSTEM received FDA 510(k) clearance on 2006-01-04, under 510(k) number K052925.

Who is the listed applicant for SMARTPREP2 CENTRIFUGE SYSTEM?

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

What is the FDA product code for SMARTPREP2 CENTRIFUGE SYSTEM?

The FDA product code for SMARTPREP2 CENTRIFUGE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Harvest Technologies, Corp. 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.

K121005ADIPREP ADIPOSE TRANSFER SYSTEMK103340SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEMK043261HARVEST GRAFT DELIVERY SYRINGEK020252SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2K011032SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA

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 CorpK070666GENESISCS COMPONENT CONCENTRATING SYSTEMPerfusion Partners & Assoc., Inc.K042473COBE ANGEL WHOLE BLOOD SEPARATION SYSTEMCobe Cardiovascular, 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.

↑