INTRAVASCULAR IMAGING SYSTEM/MODIFIED— 510(k) K910281

Name: FDA 510(k) clearance K910281
Creator: U.S. Food and Drug Administration
Published: 1991-05-13

Substantially Equivalent

Intertherapy, Inc.

FDA 510(k) clearance K910281 for INTRAVASCULAR IMAGING SYSTEM/MODIFIED, Substantially Equivalent on 1991-05-13. Applicant: Intertherapy, Inc.. Device class: 2.

Clearance details

Applicant: Intertherapy, Inc.
Product code: Code JOP
Device class: Class 2
Regulation: 21 CFR 870.2880
Advisory panel: Cardiovascular
Date received: 1991-01-23
Decision date: 1991-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOP

view all

K242662 — Falcon/Xpress (Falcon/Xpress)2024-12-18
K233976 — VasoGuard (V10, V8, V6, V4, V2)2024-07-19
K153762 — Smartdop XT62016-05-25
K131623 — SMARTDOP XT2014-01-17
K131860 — VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING2013-09-27

More clearances from Intertherapy, Inc.

view all

K913763 — INTERPRET(TM) CATHETER LINEAR TRANSLATOR1991-11-20
K912600 — INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER1991-11-19
K900305 — INTRAVASCULAR IMAGING SYSTEMS1990-04-20
K895159 — INTRAVASCULAR IMAGING SYSTEM1990-03-12

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