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FDA 510(k)

INTRA-AORTIC BALLOON-PUMP

K-Number: K790241 · 1979-02-23

ApplicantAvco Medical Products
Decision Date1979-02-23
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRA-AORTIC BALLOON-PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Avco Medical Products. It received FDA 510(k) clearance on 1979-02-23 under 510(k) number K790241. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRA-AORTIC BALLOON-PUMP?

INTRA-AORTIC BALLOON-PUMP is a medical device that received FDA 510(k) clearance on 1979-02-23. The listed applicant is Avco Medical Products. The 510(k) number is K790241.

When did INTRA-AORTIC BALLOON-PUMP receive FDA 510(k) clearance?

INTRA-AORTIC BALLOON-PUMP received FDA 510(k) clearance on 1979-02-23, under 510(k) number K790241.

Who is the listed applicant for INTRA-AORTIC BALLOON-PUMP?

The FDA 510(k) record lists Avco Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRA-AORTIC BALLOON-PUMP?

The FDA product code for INTRA-AORTIC BALLOON-PUMP is DSP.

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 Avco Medical Products 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.

K802924KONTRON PERCUTAEOUS DOUBLE-LUMENK781848PUMP, BALLOON MODEL 10K770937PUMP, BYPASS, PULSATILE, AVCOK770821PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT

Related Devices (Code: DSP)

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.

K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLCK232343AC3™ Series IABPArrow International, LLCK201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, TeleflexK190101UltraFlex IABArrow International, 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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