AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE— 510(k) K842481

Name: FDA 510(k) clearance K842481
Creator: U.S. Food and Drug Administration
Published: 1984-10-18

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K842481 for AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE, Substantially Equivalent on 1984-10-18. Applicant: American Edwards Laboratories. Device class: 2.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1984-06-25
Decision date: 1984-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, 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 American Edwards Laboratories

view all

K873485 — EDSLAB (R) OCCLUSION BALLOON CATHETER1987-12-03
K872596 — TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F301987-09-30
K872529 — THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-21987-09-15
K870444 — HOMEPRO II VOLUMETRIC INFUSION PUMP1987-04-17
K864997 — MEDTRAC VP VOLUMETRIC INFUSION PUMP1987-02-27

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