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)

CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE

K-Number: K921148 · 1992-06-16

ApplicantCardiovascular Imaging Systems, Inc.
Decision Date1992-06-16
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Imaging Systems, Inc.. It received FDA 510(k) clearance on 1992-06-16 under 510(k) number K921148. 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 CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE?

CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE is a medical device that received FDA 510(k) clearance on 1992-06-16. The listed applicant is Cardiovascular Imaging Systems, Inc.. The 510(k) number is K921148.

When did CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE receive FDA 510(k) clearance?

CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE received FDA 510(k) clearance on 1992-06-16, under 510(k) number K921148.

Who is the listed applicant for CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE?

The FDA 510(k) record lists Cardiovascular Imaging Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE?

The FDA product code for CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE 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 Cardiovascular Imaging Systems, Inc. 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.

K970049BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/K942231MICROVIEW II/MICRORAIL II CATHETERSK933517AUTOMATIC PULL BACK DEVICEK930232CVIS INSIGHT IMAGING GUIDE CATHETERK924922CVIS INSIGHT IMAGING CATHETERK930311CVIS LONGVIEW

View all 19 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.

↑