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FDA 510(k)

LEOCOR CORFLO(TM) PUMP

K-Number: K900350 · 1990-07-17

ApplicantLeocor, Inc.
Decision Date1990-07-17
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEOCOR CORFLO(TM) PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Leocor, Inc.. It received FDA 510(k) clearance on 1990-07-17 under 510(k) number K900350. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEOCOR CORFLO(TM) PUMP?

LEOCOR CORFLO(TM) PUMP is a medical device that received FDA 510(k) clearance on 1990-07-17. The listed applicant is Leocor, Inc.. The 510(k) number is K900350.

When did LEOCOR CORFLO(TM) PUMP receive FDA 510(k) clearance?

LEOCOR CORFLO(TM) PUMP received FDA 510(k) clearance on 1990-07-17, under 510(k) number K900350.

Who is the listed applicant for LEOCOR CORFLO(TM) PUMP?

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

What is the FDA product code for LEOCOR CORFLO(TM) PUMP?

The FDA product code for LEOCOR CORFLO(TM) PUMP is DXK.

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 Leocor, 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.

K924110LEOCOR CORFLO PUMP -- MODIFICATIONK911270LEOCOR GUIDING CATHETER

Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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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