Cleared Traditional

K830637 - VERTEX DIGITAL SUBSTRATION KIT

K830637 is an FDA 510(k) clearance for VERTEX DIGITAL SUBSTRATION KIT, manufactured by Professional Medical Services. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K830637 · Professional Medical Services · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1983
Decision
23d
Days
Class 2
Risk

K830637 is an FDA 510(k) clearance for the VERTEX DIGITAL SUBSTRATION KIT. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Professional Medical Services (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 23 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 Professional Medical Services devices

FDA 510(k) Submission Details - K830637

510(k) Number K830637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1983
Decision Date March 24, 1983
Days to Decision 23 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
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 352
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K830637.
CENTRAL VEIN CATHERIZATION KIT-14-690-
K830788 · Norton Performance Plastics Corp. · Apr 1983
DIAGNOSTIC INTRAVASCULAR CATHETER
K830415 · Mallinckrodt Critical Care · Apr 1983
FORGARTY BALLOON CALIBRATOR
K830734 · American Edwards Laboratories · Apr 1983
LYMPHANGIOGRAPHY SET
K830576 · Vertex Medical Corp. · Mar 1983
CATHETER CONNECTION W/INTEGRAL INJECTATE
K830523 · Gould, Inc. · Mar 1983
VARIOUS CARDIOVASCULAR PRODUCTS
K823357 · C.R. Bard, Inc. · Mar 1983