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FDA 510(k)

ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)

K-Number: K965209 · 1998-01-23

ApplicantArrow Intl., Inc.
Decision Date1998-01-23
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 1998-01-23 under 510(k) number K965209. 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 ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)?

ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) is a medical device that received FDA 510(k) clearance on 1998-01-23. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K965209.

When did ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) receive FDA 510(k) clearance?

ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) received FDA 510(k) clearance on 1998-01-23, under 510(k) number K965209.

Who is the listed applicant for ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)?

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

What is the FDA product code for ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)?

The FDA product code for ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) is DSP.

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Other records listing Arrow Intl., 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.

K100635ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504K093050ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520K071491ARROW INTERNATIONAL, INC., SURGICAL DRAPESK071998ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENTK071111NON-ABSORBABLE SILK SUTUREK060309AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES

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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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