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)

CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.

K-Number: K883888 · 1988-12-12

ApplicantAdvanced Biosearch Assn.
Decision Date1988-12-12
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biosearch Assn.. It received FDA 510(k) clearance on 1988-12-12 under 510(k) number K883888. 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 INTRAVASCULAR ULTRASONIC IMAGING SYST.?

CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. is a medical device that received FDA 510(k) clearance on 1988-12-12. The listed applicant is Advanced Biosearch Assn.. The 510(k) number is K883888.

When did CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. receive FDA 510(k) clearance?

CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. received FDA 510(k) clearance on 1988-12-12, under 510(k) number K883888.

Who is the listed applicant for CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.?

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

What is the FDA product code for CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.?

The FDA product code for CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. is DXK.

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 Advanced Biosearch Assn. 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.

K905514AUTOGENESIS(TM) AUTOMATORK854770MARTIN LAMINAR OSTEOSYNTHESIS SYSTEMK855030CHAMPY BONE PLATES & BONE SCREWSK855031MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE PK853916P.M. HIP-FEMORAL PROSTHESISK852839FREEMAN HIP

View all 22 devices →

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.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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.

↑