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FDA 510(k)

AC3™ Series IABP

K-Number: K232343 · 2023-08-30

ApplicantArrow International, LLC
Decision Date2023-08-30
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AC3™ Series IABP is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K232343. 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 AC3™ Series IABP?

AC3™ Series IABP is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Arrow International, LLC. The 510(k) number is K232343.

When did AC3™ Series IABP receive FDA 510(k) clearance?

AC3™ Series IABP received FDA 510(k) clearance on 2023-08-30, under 510(k) number K232343.

Who is the listed applicant for AC3™ Series IABP?

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

What is the FDA product code for AC3™ Series IABP?

The FDA product code for AC3™ Series IABP is DSP.

Other records listing Arrow International, LLC 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.

K250542AC3™ Range™ Intra-Aortic Balloon PumpK222341Arrow 0.2 Micron Flat Filter, GVSK201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPK200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitK190101UltraFlex IABK190117Fiberoptix IAB

View all 8 devices →

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, 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.K190117Fiberoptix 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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