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FDA 510(k)

SYSTEM 97

K-Number: K922235 · 1993-04-27

ApplicantDatascope Corp.
Decision Date1993-04-27
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYSTEM 97 is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1993-04-27 under 510(k) number K922235. 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 SYSTEM 97?

SYSTEM 97 is a medical device that received FDA 510(k) clearance on 1993-04-27. The listed applicant is Datascope Corp.. The 510(k) number is K922235.

When did SYSTEM 97 receive FDA 510(k) clearance?

SYSTEM 97 received FDA 510(k) clearance on 1993-04-27, under 510(k) number K922235.

Who is the listed applicant for SYSTEM 97?

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 SYSTEM 97?

The FDA product code for SYSTEM 97 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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