FDA 510(k)

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

K-Number: K172305 · 2017-10-12

Decision Date2017-10-12

Product CodeDSP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump is a medical device manufactured by Datascope Corp.. It received FDA 510(k) clearance on 2017-10-12 under approval 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. It is manufactured by Datascope Corp.. The 510(k) number is K172305.

When was CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump approved by the FDA?

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

What company makes CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump?

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump is manufactured by Datascope Corp..

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

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT06872905 Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease RECRUITING NCT06861361 Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients RECRUITING NCT06336655 Physiology of Unloading VA ECMO Trial RECRUITING NCT07545369 ULTRA-EVOLUT RCT: A Comparison of Latest-Generation TAVR Valves NOT_YET_RECRUITING NCT06816485 INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis RECRUITING

Related PubMed Literature

PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025)

Other Devices by Datascope Corp.

K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case K181122CARDIOSAVE Intra-Aortic Balloon Pump K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool

Related Devices (Code: DSP)

K162820AC3 Series IABP SystemArrow International, Inc. K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex K190101UltraFlex IABArrow International, Inc. K190117Fiberoptix 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.