Cleared Traditional

K863558 - URESIL CAROTID SHUNT

K863558 is an FDA 510(k) clearance for URESIL CAROTID SHUNT, manufactured by Uresil Corp.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K863558 · Uresil Corp. · Cardiovascular device
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Nov 1986
Decision
73d
Days
Class 2
Risk

K863558 is an FDA 510(k) clearance for the URESIL CAROTID SHUNT. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on November 24, 1986 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Uresil Corp. devices

FDA 510(k) Submission Details - K863558

510(k) Number K863558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1986
Decision Date November 24, 1986
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 270
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K863558.
GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA
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ASPIRATING NEEDLE, CATALOG CODE #12006
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RMI FEMORAL VENOUS DRAINAGE CANNULA
K863740 · Research Medical, Inc. · Feb 1987
TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNT
K862634 · Research Medical, Inc. · Oct 1986
RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT
K861790 · Research Medical, Inc. · Jul 1986
BARD-PARKER CAROTID SHUNT
K860136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986