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FDA 510(k)

9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON

K-Number: K892798 · 1989-09-20

ApplicantKontron Instruments, Inc.
Decision Date1989-09-20
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Kontron Instruments, Inc.. It received FDA 510(k) clearance on 1989-09-20 under 510(k) number K892798. 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 9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON?

9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON is a medical device that received FDA 510(k) clearance on 1989-09-20. The listed applicant is Kontron Instruments, Inc.. The 510(k) number is K892798.

When did 9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON receive FDA 510(k) clearance?

9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON received FDA 510(k) clearance on 1989-09-20, under 510(k) number K892798.

Who is the listed applicant for 9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON?

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

What is the FDA product code for 9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON?

The FDA product code for 9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON is DSP.

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Other records listing Kontron Instruments, 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.

K932268MODIFICATIONS TO INTRA-AORTIC BALLOONSK925248MODIFICATION OF INTRA-AORTIC BALLOON CATHETERSK923603INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATIONK905313KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT IIK9033449.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)K896437KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM

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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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