Cleared Traditional

K833965 - 8 FRENCH DILATOR 15CM, W/LUER LOCK

K833965 is an FDA 510(k) clearance for 8 FRENCH DILATOR 15CM, manufactured by Quinton, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K833965 · Quinton, Inc. · Cardiovascular device
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Dec 1983
Decision
30d
Days
Class 2
Risk

K833965 is an FDA 510(k) clearance for the 8 FRENCH DILATOR 15CM, W/LUER LOCK. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1983 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 - K833965

510(k) Number K833965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1983
Decision Date December 16, 1983
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 84
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K833965.
10.5 FRENCH DILATOR, 15CM, W/LUER LOCK
K841995 · Quinton, Inc. · Jul 1984
CARDIAC CATHETERIZATION PACK
K840671 · Professional Medical Services · Mar 1984
VERTEX PERCUTANEOUS CATHETER INTRODUC
K840017 · Professional Medical Services · Feb 1984
VESSEL DILATOR
K831190 · Medrad, Inc. · May 1983
VESSEL DILATOR
K822595 · Vertex Medical Corp. · Sep 1982
MICRO TRANSDUCER CATHETERS
K813125 · Honeywell, Inc. · Dec 1981