Cleared Traditional

K833554 - MATERIAL ADDITION LEXAN & K-RESIN

K833554 is the FDA 510(k) clearance for MATERIAL ADDITION LEXAN & K-RESIN by Procedure Products, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K833554 · Procedure Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
159d
Days
Class 2
Risk

K833554 is an FDA 510(k) clearance for the MATERIAL ADDITION LEXAN & K-RESIN. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Procedure Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 159 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 Procedure Products, Inc. devices

Submission Details

510(k) Number K833554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date March 12, 1984
Days to Decision 159 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 125d · This submission: 159d
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 256
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K833554.
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH
K842798 · American Edwards Laboratories · Aug 1984
PERCUTANEOUS ANGIOSCOPE DELIVERY CATH
K842799 · American Edwards Laboratories · Aug 1984
ADVANCED CARDIOVASCULAR-CORONARY GUID
K842195 · Advanced Cardiovascular Systems, Inc. · Jul 1984
DIAGNOSTIC RADIOLOGY CATHETERS
K834459 · American Edwards Laboratories · Feb 1984
PERCLUDER DL OCCLUDING BALLOON
K832386 · Datascope Corp. · Oct 1983
ANGIOGRAPHY KIT W/ADDIT. COMPONENTS
K831509 · Mallinckrodt Critical Care · Jun 1983