Cleared Traditional

K842195 - ADVANCED CARDIOVASCULAR-CORONARY GUID

K842195 is the FDA 510(k) clearance for ADVANCED CARDIOVASCULAR-CORONARY GUID by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K842195 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Jul 1984
Decision
39d
Days
Class 2
Risk

K842195 is an FDA 510(k) clearance for the ADVANCED CARDIOVASCULAR-CORONARY GUID. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on July 13, 1984 after a review of 39 days - a notably fast clearance 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: 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 K842195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1984
Decision Date July 13, 1984
Days to Decision 39 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
86d faster than avg
Panel avg: 125d · This submission: 39d
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 292
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K842195.
PTCA GUIDING CATHER
K844161 · Cordis Corp. · Jan 1985
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH
K842798 · American Edwards Laboratories · Aug 1984
PERCUTANEOUS ANGIOSCOPE DELIVERY CATH
K842799 · American Edwards Laboratories · Aug 1984
ELECATH HEPARIN-COATED CATHETERS
K841615 · Electro-Catheter Corp. · Jun 1984
DIAGNOSTIC RADIOLOGY CATHETERS
K834459 · American Edwards Laboratories · Feb 1984
PERCLUDER DL OCCLUDING BALLOON
K832386 · Datascope Corp. · Oct 1983