Cleared Traditional

K840175 - DOUBLE LUMEN INFUSION CATHETERS

K840175 is an FDA 510(k) clearance for DOUBLE LUMEN INFUSION CATHETERS, manufactured by Medical Components, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K840175 · Medical Components, Inc. · Cardiovascular device
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Feb 1984
Decision
24d
Days
Class 2
Risk

K840175 is an FDA 510(k) clearance for the DOUBLE LUMEN INFUSION CATHETERS. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medical Components, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 24 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 Medical Components, Inc. devices

FDA 510(k) Submission Details - K840175

510(k) Number K840175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1984
Decision Date February 10, 1984
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

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 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K840175.
MICROFUSE INTRAVENOUS CATHETER SET
K840240 · Norton Performance Plastics Corp. · Apr 1984
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
DUOFLO 6F
K833303 · Argon Medical Corp. · Dec 1983
ULTRA LIGHT RAAF CATHETER
K832784 · Quinton, Inc. · Oct 1983