Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ENDOSONICS AUTOMATIC PULL BACK DEVICE

K-Number: K962293 · 1996-09-16

ApplicantEndosonics Corp.
Decision Date1996-09-16
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ENDOSONICS AUTOMATIC PULL BACK DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Endosonics Corp.. It received FDA 510(k) clearance on 1996-09-16 under 510(k) number K962293. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSONICS AUTOMATIC PULL BACK DEVICE?

ENDOSONICS AUTOMATIC PULL BACK DEVICE is a medical device that received FDA 510(k) clearance on 1996-09-16. The listed applicant is Endosonics Corp.. The 510(k) number is K962293.

When did ENDOSONICS AUTOMATIC PULL BACK DEVICE receive FDA 510(k) clearance?

ENDOSONICS AUTOMATIC PULL BACK DEVICE received FDA 510(k) clearance on 1996-09-16, under 510(k) number K962293.

Who is the listed applicant for ENDOSONICS AUTOMATIC PULL BACK DEVICE?

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 ENDOSONICS AUTOMATIC PULL BACK DEVICE?

The FDA product code for ENDOSONICS AUTOMATIC PULL BACK DEVICE is ITX.

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 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 SYSTEMK950276MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM

View all 15 devices →

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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.

↑