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FDA 510(k)

INTRAVASCULAR IMAGING SYSTEM/MODIFIED

K-Number: K910281 · 1991-05-13

ApplicantIntertherapy, Inc.
Decision Date1991-05-13
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRAVASCULAR IMAGING SYSTEM/MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Intertherapy, Inc.. It received FDA 510(k) clearance on 1991-05-13 under 510(k) number K910281. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAVASCULAR IMAGING SYSTEM/MODIFIED?

INTRAVASCULAR IMAGING SYSTEM/MODIFIED is a medical device that received FDA 510(k) clearance on 1991-05-13. The listed applicant is Intertherapy, Inc.. The 510(k) number is K910281.

When did INTRAVASCULAR IMAGING SYSTEM/MODIFIED receive FDA 510(k) clearance?

INTRAVASCULAR IMAGING SYSTEM/MODIFIED received FDA 510(k) clearance on 1991-05-13, under 510(k) number K910281.

Who is the listed applicant for INTRAVASCULAR IMAGING SYSTEM/MODIFIED?

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

What is the FDA product code for INTRAVASCULAR IMAGING SYSTEM/MODIFIED?

The FDA product code for INTRAVASCULAR IMAGING SYSTEM/MODIFIED is JOP.

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 Intertherapy, 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.

K913763INTERPRET(TM) CATHETER LINEAR TRANSLATORK912600INTERPRET(TM) INTRAVASCULAR IMAGING CATHETERK900305INTRAVASCULAR IMAGING SYSTEMSK895159INTRAVASCULAR IMAGING SYSTEM

Related Devices (Code: JOP)

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.

K242662Falcon/Xpress (Falcon/Xpress)Viasonix , Ltd.K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLCK153762Smartdop XT6Koven Technology, Inc.K131860VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDINGUs Vascular, LLCK111416FALCONViasonix , Ltd.K071730STUDIODOP VICORDERSkidmore Medical, Limited

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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