SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe— 510(k) K220981

Name: FDA 510(k) clearance K220981
Creator: U.S. Food and Drug Administration
Published: 2023-04-20

Substantially Equivalent

Fehling Surgical Instruments, Inc.

FDA 510(k) clearance K220981 for SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe, Substantially Equivalent on 2023-04-20. Applicant: Fehling Surgical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Fehling Surgical Instruments, Inc.
Product code: Code DWP
Device class: Class 2
Regulation: 21 CFR 870.4475
Advisory panel: Cardiovascular
Date received: 2022-04-04
Decision date: 2023-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWP

view all

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
K030788 — KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS2003-07-12

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