Cleared Traditional

CARDIOSEARCH RIGHT ATRIAL CATH- (K833873) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833873 · Cardio Search, Inc. · Cardiovascular device
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Jun 1984
Decision
216d
Days
Class 2
Risk

K833873 is an FDA 510(k) clearance for the CARDIOSEARCH RIGHT ATRIAL CATH-. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cardio Search, Inc. (Walker, US). The FDA issued a Cleared decision on June 11, 1984 after a review of 216 days - an extended review 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: 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 Cardio Search, Inc. devices

Submission Details

510(k) Number K833873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1983
Decision Date June 11, 1984
Days to Decision 216 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 125d · This submission: 216d
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 317
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K833873.
BARD-PARKER IRRIGATION CATHETER
K852099 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985
MULTIPRO CATHETER
K841797 · Shiley, Inc. · Aug 1984
RAAF DUAL LUMEN CATHETER
K842176 · Quinton, Inc. · Jul 1984
MAHURKAR DUAL LIMEN FEMORAL CATHETER
K834109 · Quinton, Inc. · Feb 1984
ULTRA LIGHT RAAF CATHETER
K832784 · Quinton, Inc. · Oct 1983
AMPLATZ HEPARIN COATED CATHETER
K832178 · Cook, Inc. · Aug 1983