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FDA 510(k)

9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)

K-Number: K903344 · 1991-01-15

ApplicantKontron Instruments, Inc.
Decision Date1991-01-15
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) 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 1991-01-15 under 510(k) number K903344. 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 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)?

9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) is a medical device that received FDA 510(k) clearance on 1991-01-15. The listed applicant is Kontron Instruments, Inc.. The 510(k) number is K903344.

When did 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) receive FDA 510(k) clearance?

9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) received FDA 510(k) clearance on 1991-01-15, under 510(k) number K903344.

Who is the listed applicant for 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)?

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 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)?

The FDA product code for 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) 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 IIK896437KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEMK8922229.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON

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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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