Cleared Traditional

DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (K000704) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K000704 · Dmc Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
78d
Days
Class 1
Risk

K000704 is an FDA 510(k) clearance for the DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS). Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Dmc Medical, Ltd. (Fullerton, US). The FDA issued a Cleared decision on May 19, 2000 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dmc Medical, Ltd. devices

Submission Details

510(k) Number K000704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBX Catheter, Irrigation

All 76
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K000704.
JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING
K960955 · Baxter Healthcare Corp · May 1996
VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE
K925176 · Boston Scientific Corp · Apr 1993
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
K905614 · Baxter Healthcare Corp · Mar 1991
TIDAL DISTENSION IRRIGATION SET
K841362 · Abbott Laboratories · Aug 1984