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)

PUMP, BALLOON MODEL 10

K-Number: K781848 · 1979-01-23

ApplicantAvco Medical Products
Decision Date1979-01-23
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PUMP, BALLOON MODEL 10 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 1979-01-23 under 510(k) number K781848. 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 PUMP, BALLOON MODEL 10?

PUMP, BALLOON MODEL 10 is a medical device that received FDA 510(k) clearance on 1979-01-23. The listed applicant is Avco Medical Products. The 510(k) number is K781848.

When did PUMP, BALLOON MODEL 10 receive FDA 510(k) clearance?

PUMP, BALLOON MODEL 10 received FDA 510(k) clearance on 1979-01-23, under 510(k) number K781848.

Who is the listed applicant for PUMP, BALLOON MODEL 10?

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 PUMP, BALLOON MODEL 10?

The FDA product code for PUMP, BALLOON MODEL 10 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-LUMENK790241INTRA-AORTIC BALLOON-PUMPK770937PUMP, 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.

↑