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FDA 510(k)

IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U

K-Number: K970689 · 1998-06-04

ApplicantArrow Intl., Inc.
Decision Date1998-06-04
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U 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 1998-06-04 under 510(k) number K970689. 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 IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U?

IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U is a medical device that received FDA 510(k) clearance on 1998-06-04. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K970689.

When did IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U receive FDA 510(k) clearance?

IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U received FDA 510(k) clearance on 1998-06-04, under 510(k) number K970689.

Who is the listed applicant for IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U?

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 IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U?

The FDA product code for IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U is DSP.

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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