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FDA 510(k)

10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON

K-Number: K892797 · 1989-09-20

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

Device Summary

10 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 K892797. 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 10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON?

10 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 K892797.

When did 10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON receive FDA 510(k) clearance?

10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON received FDA 510(k) clearance on 1989-09-20, under 510(k) number K892797.

Who is the listed applicant for 10 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 10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON?

The FDA product code for 10 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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