FOGARTY FLEXIBLE PROBE— 510(k) K812935

Name: FDA 510(k) clearance K812935
Creator: U.S. Food and Drug Administration
Published: 1981-11-16

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K812935 for FOGARTY FLEXIBLE PROBE, Substantially Equivalent on 1981-11-16. Applicant: American Edwards Laboratories. Device class: 2.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code DWP
Device class: Class 2
Regulation: 21 CFR 870.4475
Advisory panel: Cardiovascular
Date received: 1981-10-20
Decision date: 1981-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWP

view all

K220981 — SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe2023-04-20
K183438 — Geomed Vascular Dilators2019-09-03
K163524 — Vessel Dilator2017-06-29
K130896 — VASCULAR PROBE, VASCULAR PROBE ES2013-04-24
K100518 — INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-70542010-08-31

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.