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FDA 510(k)

VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300)

K-Number: K944004 · 1995-05-04

ApplicantEndosonics Corp.
Decision Date1995-05-04
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) is the device name listed in this FDA 510(k) record. The listed applicant is Endosonics Corp.. It received FDA 510(k) clearance on 1995-05-04 under 510(k) number K944004. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300)?

VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) is a medical device that received FDA 510(k) clearance on 1995-05-04. The listed applicant is Endosonics Corp.. The 510(k) number is K944004.

When did VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) receive FDA 510(k) clearance?

VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) received FDA 510(k) clearance on 1995-05-04, under 510(k) number K944004.

Who is the listed applicant for VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300)?

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

What is the FDA product code for VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300)?

The FDA product code for VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) is IYO.

Related Clinical Trials

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Other records listing Endosonics 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.

K000820AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700K990271ENDOSONICS TRAK BACK DEVICEK982329VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)K965223RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEMK963290COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEMK962293ENDOSONICS AUTOMATIC PULL BACK DEVICE

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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