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FDA 510(k)

KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II

K-Number: K905313 · 1991-06-19

ApplicantKontron Instruments, Inc.
Decision Date1991-06-19
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II 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 1991-06-19 under 510(k) number K905313. 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 INTRA-AORTIC BALLOON PUMP, MODEL KAAT II?

KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II is a medical device that received FDA 510(k) clearance on 1991-06-19. The listed applicant is Kontron Instruments, Inc.. The 510(k) number is K905313.

When did KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II receive FDA 510(k) clearance?

KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II received FDA 510(k) clearance on 1991-06-19, under 510(k) number K905313.

Who is the listed applicant for KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II?

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 KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II?

The FDA product code for KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II 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 - MODIFICATIONK9033449.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)K896437KONTRON 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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