Cleared Traditional

K936282 - TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)

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

K936282 · Cordis Neurovascular, Inc. · Cardiovascular device
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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

FDA 510(k) Submission Details - K936282

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.

DQO Device Classification - Class 2, Special Controls

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 403
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K936282.
CARDIAC CATHETERIZATION KIT
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K942939 · Cordis Corp. · Aug 1994
MICROVIEW II/MICRORAIL II CATHETERS
K942231 · Cardiovascular Imaging Systems, Inc. · Aug 1994
CARDIAC CATHETERIZATION TRAY
K931560 · Clinipad Corp. · Jul 1994
HAND CONTROLLED SYRINGE
K942329 · Abbott Laboratories · Jun 1994
PRESSURE MONITORING EXTENSION
K942482 · Surgical Technologies, Inc. · Jun 1994