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FDA 510(k)

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

K-Number: K112327 · 2011-09-09

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

Device Summary

SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES 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 2011-09-09 under 510(k) number K112327. 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 SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES?

SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2011-09-09. The listed applicant is Cardiac Assist, Maquet Cardiovascular, LLC. The 510(k) number is K112327.

When did SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES receive FDA 510(k) clearance?

SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES received FDA 510(k) clearance on 2011-09-09, under 510(k) number K112327.

Who is the listed applicant for SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES?

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

The FDA product code for SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES 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.

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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.

K112372CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP

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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