3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)— 510(k) K861985

Clearance details

Applicant

3M Company

Product code

Code MVR

Device class

Class 2

Regulation

21 CFR 878.4300

Advisory panel

General, Plastic Surgery

Date received

1986-05-22

Decision date

1986-12-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cottae Grove, MN, US

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• Z-1685-2020 — GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.Class II·Terminated·Baxter Healthcare Corporation·20200305
• Z-1686-2020 — GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.Class II·Terminated·Baxter Healthcare Corporation·20200305
• Z-1687-2020 — GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.Class II·Terminated·Baxter Healthcare Corporation·20200305

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K861985.