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FDA 510(k)

DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES

K-Number: K041281 · 2004-06-07

ApplicantDatascope Corp.
Decision Date2004-06-07
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2004-06-07 under 510(k) number K041281. 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 DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES?

DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2004-06-07. The listed applicant is Datascope Corp.. The 510(k) number is K041281.

When did DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES receive FDA 510(k) clearance?

DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES received FDA 510(k) clearance on 2004-06-07, under 510(k) number K041281.

Who is the listed applicant for DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES?

The FDA 510(k) record lists Datascope Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES?

The FDA product code for DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES is DSP.

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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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