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FDA 510(k)

CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX

K-Number: K031636 · 2003-08-11

ApplicantDatascope Corp.
Decision Date2003-08-11
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2003-08-11 under 510(k) number K031636. 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 CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX?

CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX is a medical device that received FDA 510(k) clearance on 2003-08-11. The listed applicant is Datascope Corp.. The 510(k) number is K031636.

When did CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX receive FDA 510(k) clearance?

CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX received FDA 510(k) clearance on 2003-08-11, under 510(k) number K031636.

Who is the listed applicant for CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX?

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 CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX?

The FDA product code for CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX 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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