GORE-TEX TUNNELER— 510(k) K844584

Name: FDA 510(k) clearance K844584
Creator: U.S. Food and Drug Administration
Published: 1985-01-24

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K844584 for GORE-TEX TUNNELER, Substantially Equivalent on 1985-01-24. Applicant: W. L. Gore & Associates, Inc.. Device class: 1.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1984-11-23
Decision date: 1985-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWS

view all

K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 106262002-10-09
K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)1997-01-30
K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS1996-11-19
K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY1996-05-15
K960139 — G.E. STERILE ANGIOGRAPHIC TRAY1996-04-19

More clearances from W. L. Gore & Associates, Inc.

view all

K250410 — GORE® Tri-Lobe Balloon Catheter2025-06-02
K240083 — GORE® PROPATEN® Vascular Graft2024-03-01
K232312 — GORE® PROPATEN® Vascular Graft2024-01-09
K233551 — GORE® ACUSEAL Vascular Graft2023-12-19
K231505 — GORE® ACUSEAL Vascular Graft2023-06-23

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