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FDA 510(k)

CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP

K-Number: K112372 · 2011-09-15

ApplicantCardiac Assist, Maquet Cardiovascular, LLC
Decision Date2011-09-15
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Assist, Maquet Cardiovascular, LLC. It received FDA 510(k) clearance on 2011-09-15 under 510(k) number K112372. 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 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP?

CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP is a medical device that received FDA 510(k) clearance on 2011-09-15. The listed applicant is Cardiac Assist, Maquet Cardiovascular, LLC. The 510(k) number is K112372.

When did CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP receive FDA 510(k) clearance?

CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP received FDA 510(k) clearance on 2011-09-15, under 510(k) number K112372.

Who is the listed applicant for CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP?

The FDA 510(k) record lists Cardiac Assist, Maquet Cardiovascular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP?

The FDA product code for CARDIOSAVE HYBRID 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cardiac Assist, Maquet Cardiovascular, LLC 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.

K112327SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES

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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