Cleared Traditional

K831563 - CORONARY GUIDING CATHETER-MODIFIED

K831563 is the FDA 510(k) clearance for CORONARY GUIDING CATHETER-MODIFIED by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K831563 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Jun 1983
Decision
45d
Days
Class 2
Risk

K831563 is an FDA 510(k) clearance for the CORONARY GUIDING CATHETER-MODIFIED. 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 June 30, 1983 after a review of 45 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K831563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1983
Decision Date June 30, 1983
Days to Decision 45 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
80d faster than avg
Panel avg: 125d · This submission: 45d
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 K831563.
AMPLATZ HEPARIN COATED CATHETER
K832178 · Cook, Inc. · Aug 1983
PERCUTANEOUS CATHETER INSERTION TRAY
K831729 · American Pharmaseal Div. Ahsc · Jul 1983
CATHETER INSERTION TRAYS, VARIOUS #'S
K831807 · American Pharmaseal Div. Ahsc · Jul 1983
CORONARY INFUSION CATHETER
K831717 · Advanced Cardiovascular Systems, Inc. · Jun 1983
INTRAOPERATIVE BALLOON DILATION CATH.
K822393 · Advanced Cardiovascular Systems, Inc. · Nov 1982
MULTIPURPOSE CATHETER
K821189 · Advanced Cardiovascular Systems, Inc. · Jul 1982