INTRAVASCULAR IMAGING SYSTEMS— 510(k) K900305

Name: FDA 510(k) clearance K900305
Creator: U.S. Food and Drug Administration
Published: 1990-04-20

Substantially Equivalent

Intertherapy, Inc.

FDA 510(k) clearance K900305 for INTRAVASCULAR IMAGING SYSTEMS, Substantially Equivalent on 1990-04-20. Applicant: Intertherapy, Inc.. Device class: 2.

Clearance details

Applicant: Intertherapy, Inc.
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1990-01-21
Decision date: 1990-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYK

view all

K253842 — Vena MicroAngioscope System2026-01-28
K251767 — Vena MicroAngioscope System2025-10-01
K062340 — CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM2006-11-30
K050808 — CORONARY SINUS ACCESS KIT, MODEL KCS8F-012005-07-28
K011793 — KSEA FIBERSCOPE2002-04-17

More clearances from Intertherapy, Inc.

view all

K913763 — INTERPRET(TM) CATHETER LINEAR TRANSLATOR1991-11-20
K912600 — INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER1991-11-19
K910281 — INTRAVASCULAR IMAGING SYSTEM/MODIFIED1991-05-13
K895159 — INTRAVASCULAR IMAGING SYSTEM1990-03-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.