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FDA 510(k)

KONTRON PERCUTAEOUS DOUBLE-LUMEN

K-Number: K802924 · 1981-03-11

ApplicantAvco Medical Products
Decision Date1981-03-11
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KONTRON PERCUTAEOUS DOUBLE-LUMEN 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 1981-03-11 under 510(k) number K802924. 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 KONTRON PERCUTAEOUS DOUBLE-LUMEN?

KONTRON PERCUTAEOUS DOUBLE-LUMEN is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Avco Medical Products. The 510(k) number is K802924.

When did KONTRON PERCUTAEOUS DOUBLE-LUMEN receive FDA 510(k) clearance?

KONTRON PERCUTAEOUS DOUBLE-LUMEN received FDA 510(k) clearance on 1981-03-11, under 510(k) number K802924.

Who is the listed applicant for KONTRON PERCUTAEOUS DOUBLE-LUMEN?

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 KONTRON PERCUTAEOUS DOUBLE-LUMEN?

The FDA product code for KONTRON PERCUTAEOUS DOUBLE-LUMEN is DSP.

Related Clinical Trials

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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.

K790241INTRA-AORTIC BALLOON-PUMPK781848PUMP, 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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