Cleared Traditional

K830576 - LYMPHANGIOGRAPHY SET

K830576 is an FDA 510(k) clearance for LYMPHANGIOGRAPHY SET, manufactured by Vertex Medical Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K830576 · Vertex Medical Corp. · Cardiovascular device
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Mar 1983
Decision
22d
Days
Class 2
Risk

K830576 is an FDA 510(k) clearance for the LYMPHANGIOGRAPHY SET. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Vertex Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1983 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight 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 Vertex Medical Corp. devices

FDA 510(k) Submission Details - K830576

510(k) Number K830576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1983
Decision Date March 17, 1983
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 411
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K830576.
DIAGNOSTIC INTRAVASCULAR CATHETER
K830415 · Mallinckrodt Critical Care · Apr 1983
FORGARTY BALLOON CALIBRATOR
K830734 · American Edwards Laboratories · Apr 1983
VERTEX DIGITAL SUBSTRATION KIT
K830637 · Professional Medical Services · Mar 1983
CATHETER CONNECTION W/INTEGRAL INJECTATE
K830523 · Gould, Inc. · Mar 1983
VARIOUS CARDIOVASCULAR PRODUCTS
K823357 · C.R. Bard, Inc. · Mar 1983
POLYETHYLENE MONITORING CONNECTORS
K830420 · Vertex Medical Corp. · Feb 1983