Cleared Traditional

K844800 - OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CA...

K844800 is the FDA 510(k) clearance for OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CA... by Vas-Cath of Canada , Ltd.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K844800 · Vas-Cath of Canada , Ltd. · Cardiovascular device
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May 1985
Decision
156d
Days
Class 2
Risk

K844800 is an FDA 510(k) clearance for the OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Vas-Cath of Canada , Ltd. (Ontario, L5a 3v3, CA). The FDA issued a Cleared decision on May 16, 1985 after a review of 156 days - an extended review 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: 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 Vas-Cath of Canada , Ltd. devices

Submission Details

510(k) Number K844800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1984
Decision Date May 16, 1985
Days to Decision 156 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 237
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K844800.
ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP
K860580 · Advanced Cardiovascular Systems, Inc. · Mar 1986
MODIFIED CORDIS PTCA GUIDING CATHETERS
K854576 · Cordis Corp. · Feb 1986
DIAGNOSTIC INTRAVASCULAR CATHETERS
K853182 · Mallinckrodt Critical Care · Jan 1986
LARIAT CATHETER
K844598 · Mallinckrodt Critical Care · Feb 1985
PTCA GUIDING CATHER
K844161 · Cordis Corp. · Jan 1985
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH
K842798 · American Edwards Laboratories · Aug 1984