Cleared Traditional

K863684 - URESIL SUBCLAVIAN CATHETER

K863684 is an FDA 510(k) clearance for URESIL SUBCLAVIAN CATHETER, manufactured by Uresil Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K863684 · Uresil Corp. · Cardiovascular device
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Jan 1987
Decision
109d
Days
Class 2
Risk

K863684 is an FDA 510(k) clearance for the URESIL SUBCLAVIAN CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 109 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 Uresil Corp. devices

FDA 510(k) Submission Details - K863684

510(k) Number K863684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1986
Decision Date January 06, 1987
Days to Decision 109 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
16d faster than avg
Panel avg: 125d · This submission: 109d
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 600
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K863684.
CENTRAL VENOUS CATHETER
K870075 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
MEDI-TECH SELECTIVE TORQUE CATHETER
K864118 · Medi-Tech, Inc. · Apr 1987
ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY
K870675 · Quinton, Inc. · Apr 1987
VEIN VALVE CUTTER
K862724 · American Edwards Laboratories · Jan 1987
URESIL IRRIGATION CATHETER
K863564 · Uresil Corp. · Oct 1986
TRACKER INFUSION CATHETER
K862117 · Target Therapeutics · Oct 1986