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FDA 510(k)

9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM

K-Number: K963104 · 1997-02-04

ApplicantArrow Intl., Inc.
Decision Date1997-02-04
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM 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 1997-02-04 under 510(k) number K963104. 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.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM?

9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K963104.

When did 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM receive FDA 510(k) clearance?

9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM received FDA 510(k) clearance on 1997-02-04, under 510(k) number K963104.

Who is the listed applicant for 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM?

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 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM?

The FDA product code for 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM is DSP.

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Other records listing Arrow Intl., Inc. as applicant

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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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