Cleared Traditional

K832784 - ULTRA LIGHT RAAF CATHETER

K832784 is an FDA 510(k) clearance for ULTRA LIGHT RAAF CATHETER, manufactured by Quinton, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K832784 · Quinton, Inc. · Cardiovascular device
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Oct 1983
Decision
65d
Days
Class 2
Risk

K832784 is an FDA 510(k) clearance for the ULTRA LIGHT RAAF CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1983 after a review of 65 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 Quinton, Inc. devices

FDA 510(k) Submission Details - K832784

510(k) Number K832784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1983
Decision Date October 20, 1983
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
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 810
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K832784.
DOUBLE LUMEN INFUSION CATHETERS
K840175 · Medical Components, Inc. · Feb 1984
MAHURKAR DUAL LIMEN FEMORAL CATHETER
K834109 · Quinton, Inc. · Feb 1984
DUOFLO 6F
K833303 · Argon Medical Corp. · Dec 1983
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