Cleared Traditional

K833801 - RIGHT CORONARY GUIDING CATHETER

K833801 is the FDA 510(k) clearance for RIGHT CORONARY GUIDING CATHETER by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K833801 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Mar 1984
Decision
132d
Days
Class 2
Risk

K833801 is an FDA 510(k) clearance for the RIGHT CORONARY GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K833801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1983
Decision Date March 12, 1984
Days to Decision 132 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 125d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 588
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K833801.
RAAF DUAL LUMEN CATHETER
K842176 · Quinton, Inc. · Jul 1984
CENTRAL VENOUS ACCESS CATHETER CVAC-XX
K841587 · Gish Biomedical, Inc. · Jun 1984
MICROFUSE INTRAVENOUS CATHETER SET
K840240 · Norton Performance Plastics Corp. · Apr 1984
RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI
K840336 · Arrow Intl., Inc. · Feb 1984
DOUBLE LUMEN INFUSION CATHETERS
K840175 · Medical Components, Inc. · Feb 1984
MAHURKAR DUAL LIMEN FEMORAL CATHETER
K834109 · Quinton, Inc. · Feb 1984