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FDA 510(k)

DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL

K-Number: K821065 · 1982-08-19

ApplicantDatascope Corp.
Decision Date1982-08-19
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1982-08-19 under 510(k) number K821065. 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 10.5 FRENCH INTRA-AORTIC BAL?

DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL is a medical device that received FDA 510(k) clearance on 1982-08-19. The listed applicant is Datascope Corp.. The 510(k) number is K821065.

When did DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL receive FDA 510(k) clearance?

DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL received FDA 510(k) clearance on 1982-08-19, under 510(k) number K821065.

Who is the listed applicant for DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL?

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 10.5 FRENCH INTRA-AORTIC BAL?

The FDA product code for DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL is DSP.

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Other records listing Datascope Corp. as applicant

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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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