Cleared Traditional

K936282 - TRANSIT INFUSION CATHETER (NEUROVASCULA...

K936282 is the FDA 510(k) clearance for TRANSIT INFUSION CATHETER (NEUROVASCULA... by Cordis Neurovascular, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K936282 · Cordis Neurovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
200d
Days
Class 2
Risk

K936282 is an FDA 510(k) clearance for the TRANSIT INFUSION CATHETER (NEUROVASCULAR USE). Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cordis Neurovascular, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on July 18, 1994 after a review of 200 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 Cordis Neurovascular, Inc. devices

Submission Details

510(k) Number K936282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1993
Decision Date July 18, 1994
Days to Decision 200 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 125d · This submission: 200d
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 277
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K936282.
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
K943739 · Mallinckrodt Medical · Nov 1994
CARDIAC CATHETERIZATION KIT
K932141 · Abbott Laboratories · Sep 1994
CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM
K942939 · Cordis Corp. · Aug 1994
HAND CONTROLLED SYRINGE
K942329 · Abbott Laboratories · Jun 1994
DYE MANAGEMENT SYSTEM
K941254 · Abbott Laboratories · Jun 1994
TRANSIT INFUSION CATHETER
K936260 · Cordis Corp. · May 1994