Cleared Traditional

DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)

K000704 · Dmc Medical, Ltd. · General & Plastic Surgery
May 2000
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K000704 is an FDA 510(k) clearance for the DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS), a Catheter, Irrigation (Class I — General Controls, product code GBX), submitted by Dmc Medical, Ltd. (Fullerton, US). The FDA issued a Cleared decision on May 19, 2000, 78 days after receiving the submission on March 2, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number K000704 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2000
Decision Date May 19, 2000
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GBX — Catheter, Irrigation
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4200