Cleared Traditional

K823191 - DISPOSABLE PLASTIC STOPCOCK

K823191 is an FDA 510(k) clearance for DISPOSABLE PLASTIC STOPCOCK, manufactured by Vertex Medical Corp.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K823191 · Vertex Medical Corp. · Cardiovascular device
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Dec 1982
Decision
65d
Days
Class 2
Risk

K823191 is an FDA 510(k) clearance for the DISPOSABLE PLASTIC STOPCOCK. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Vertex Medical Corp. (Walker, US). The FDA issued a Cleared decision on December 30, 1982 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 - K823191

510(k) Number K823191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1982
Decision Date December 30, 1982
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 171
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K823191.
ANGIOPLASTY INFLATION DEVICE & CARTR
K834107 · Cordis Corp. · Jan 1984
DIGITAL INJECTOR SYS
K833138 · Sybron Corp. · Nov 1983
BACKSTOP VALVE W/SIDE ARM
K823190 · Vertex Medical Corp. · Dec 1982
TUOHY-BORST ADAPTER W/SIDE ARM
K823192 · Vertex Medical Corp. · Dec 1982
VERTEX MONITORING CATHETER
K823253 · Vertex Medical Corp. · Dec 1982
REUSABLE METAL STOPCOCK
K823254 · Vertex Medical Corp. · Dec 1982