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FDA 510(k)

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump

K-Number: K172305 · 2017-10-12

ApplicantDatascope Corp.
Decision Date2017-10-12
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K172305. 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/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump?

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Datascope Corp.. The 510(k) number is K172305.

When did CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump receive FDA 510(k) clearance?

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump received FDA 510(k) clearance on 2017-10-12, under 510(k) number K172305.

Who is the listed applicant for CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump?

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/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump?

The FDA product code for CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump is DSP.

Related Clinical Trials

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.

NCT06336655Physiology of Unloading VA ECMO TrialRECRUITINGNCT06049654Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve IndicationRECRUITINGNCT07761455Prophylactic IABP in Delayed-Presentation Anterior STEMINOT_YET_RECRUITINGNCT07794306Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic AnnuliNOT_YET_RECRUITING

Other records listing Datascope Corp. 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.

K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolK181122CARDIOSAVE Intra-Aortic Balloon PumpK163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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