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FDA 510(k)

MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER

K-Number: K120868 · 2012-04-20

ApplicantDatascope Corp., Cardiac Assist Division
Decision Date2012-04-20
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp., Cardiac Assist Division. It received FDA 510(k) clearance on 2012-04-20 under 510(k) number K120868. 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 MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER?

MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2012-04-20. The listed applicant is Datascope Corp., Cardiac Assist Division. The 510(k) number is K120868.

When did MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER receive FDA 510(k) clearance?

MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER received FDA 510(k) clearance on 2012-04-20, under 510(k) number K120868.

Who is the listed applicant for MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER?

The FDA 510(k) record lists Datascope Corp., Cardiac Assist Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER?

The FDA product code for MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER 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 Datascope Corp., Cardiac Assist Division 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.

K122405AIR-BAND RADIAL COMPRESSION DEVICEK122628SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIESK091449DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02

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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