VESSEL-CLUDE— 510(k) K771701

Clearance details

Applicant

Med General

Product code

Code GDJ

Device class

Class 1

Regulation

21 CFR 878.4800

Advisory panel

General, Plastic Surgery

Date received

1977-09-08

Decision date

1977-12-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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• Z-0293-2020 — (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package, 5 packages/ shelf box, 10 shelf boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx; (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301, 2 clamps per package, 6 packages/box, 50 boxes/case, Sterile, Rx; and (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401, 2 clamps per package, 5 packages/box, 50 boxes/case. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.Class II·Terminated·Argon Medical Devices, Inc·20181016

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K771701.