Cleared Traditional

K930194 - HEMOSTASIS VALVE AND TUBING SET

K930194 is the FDA 510(k) clearance for HEMOSTASIS VALVE AND TUBING SET by Opticon Medical, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 319
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K930194.
EXACTA PERCUTANEOUS INTRODUCER SHEATH
K941428 · Ohmeda Medical · Jul 1994
ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE
K934624 · Advanced Cardiovascular Systems, Inc. · Apr 1994
BURRON CARDIOVASCULAR ANGESTAT(TM)
K931743 · B.Braun Medical, Inc. · Nov 1993
CORDIS CATHETER SHEATH INTRODUCER
K932733 · Cordis Corp. · Aug 1993
ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET
K930057 · B.Braun Medical, Inc. · Aug 1993
CORDIS NIHON CATHETER SHEATH INTRODUCER
K931102 · Cordis Corp. · May 1993