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FDA 510(k)

CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600

K-Number: K911384 · 1991-06-25

ApplicantEndosonics Corp.
Decision Date1991-06-25
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 is the device name listed in this FDA 510(k) record. The listed applicant is Endosonics Corp.. It received FDA 510(k) clearance on 1991-06-25 under 510(k) number K911384. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600?

CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 is a medical device that received FDA 510(k) clearance on 1991-06-25. The listed applicant is Endosonics Corp.. The 510(k) number is K911384.

When did CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 receive FDA 510(k) clearance?

CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 received FDA 510(k) clearance on 1991-06-25, under 510(k) number K911384.

Who is the listed applicant for CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600?

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 CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600?

The FDA product code for CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 is DXK.

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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: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K904832MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYSTHewlett-Packard Co.

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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