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FDA 510(k)

8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,

K-Number: K963920 · 1997-06-17

ApplicantArrow Intl., Inc.
Decision Date1997-06-17
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, 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 1997-06-17 under 510(k) number K963920. 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 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,?

8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, is a medical device that received FDA 510(k) clearance on 1997-06-17. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K963920.

When did 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, receive FDA 510(k) clearance?

8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, received FDA 510(k) clearance on 1997-06-17, under 510(k) number K963920.

Who is the listed applicant for 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,?

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 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,?

The FDA product code for 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, 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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