Cleared Traditional

K930194 - HEMOSTASIS VALVE AND TUBING SET

K930194 is an FDA 510(k) clearance for HEMOSTASIS VALVE AND TUBING SET, manufactured by Opticon Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K930194 · Opticon Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
251d
Days
Class 2
Risk

K930194 is an FDA 510(k) clearance for the HEMOSTASIS VALVE AND TUBING SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Opticon Medical, Inc. (Gurnee, US). The FDA issued a Cleared decision on September 22, 1993 after a review of 251 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Opticon Medical, Inc. devices

FDA 510(k) Submission Details - K930194

510(k) Number K930194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1993
Decision Date September 22, 1993
Days to Decision 251 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 125d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 564
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K930194.
REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET
K932370 · Remington Medical, Inc. · Nov 1993
BURRON CARDIOVASCULAR ANGESTAT(TM)
K931743 · B.Braun Medical, Inc. · Nov 1993
MULTI-PORT Y INTRODUCER SET
K931587 · Thomas Medical Products, Inc. · Oct 1993
INTROPEEL
K930801 · Menlo Care, Inc. · Sep 1993
INTROPEEL V
K931218 · Menlo Care, Inc. · Sep 1993
LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES
K931662 · Pace Medical · Aug 1993