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FDA 510(k)

9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER

K-Number: K943919 · 1995-03-23

ApplicantBoston Scientific Corp
Decision Date1995-03-23
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1995-03-23 under 510(k) number K943919. 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 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER?

9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER is a medical device that received FDA 510(k) clearance on 1995-03-23. The listed applicant is Boston Scientific Corp. The 510(k) number is K943919.

When did 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER receive FDA 510(k) clearance?

9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER received FDA 510(k) clearance on 1995-03-23, under 510(k) number K943919.

Who is the listed applicant for 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER?

The FDA product code for 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER is DSP.

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Other records listing Boston Scientific 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.

K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)K231328LUX-Dx II (M302); LUX-Dx II+ (M312)K133566ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUSK133208INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEMK131700SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARESK131914OFFROAD RE-ENTRY CATHETER SYSTEM

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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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