Cleared Traditional

K833573 - CENTRAL VEIN CATH. TRAY CC-20-1420

K833573 is the FDA 510(k) clearance for CENTRAL VEIN CATH. TRAY CC-20-1420 by Intermed, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K833573 · Intermed, Inc. · Cardiovascular device
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Jan 1984
Decision
91d
Days
Class 2
Risk

K833573 is an FDA 510(k) clearance for the CENTRAL VEIN CATH. TRAY CC-20-1420. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Intermed, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1984 after a review of 91 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 Intermed, Inc. devices

Submission Details

510(k) Number K833573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date January 11, 1984
Days to Decision 91 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 faster than avg
Panel avg: 125d · This submission: 91d
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 484
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K833573.
RIGHT CORONARY GUIDING CATHETER
K833801 · Advanced Cardiovascular Systems, Inc. · Mar 1984
RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI
K840336 · Arrow Intl., Inc. · Feb 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
CORONARY GUIDING CATHETER-MODIFIED
K831563 · Advanced Cardiovascular Systems, Inc. · Jun 1983