Cleared Traditional

K860497 - CAROTID BALLOON SHUNT

K860497 is an FDA 510(k) clearance for CAROTID BALLOON SHUNT, manufactured by Imodex, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K860497 · Imodex, Inc. · Cardiovascular device
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May 1986
Decision
107d
Days
Class 2
Risk

K860497 is an FDA 510(k) clearance for the CAROTID BALLOON SHUNT. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Imodex, Inc. (St. Clair Shores, US). The FDA issued a Cleared decision on May 28, 1986 after a review of 107 days - within the typical 510(k) review window.

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: 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 Imodex, Inc. devices

FDA 510(k) Submission Details - K860497

510(k) Number K860497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1986
Decision Date May 28, 1986
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
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 345
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K860497.
BARD-PARKER CAROTID SHUNT
K860136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
STOCKERT-SHILEY AORTIC ROOT CANNULAE
K861310 · Shiley, Inc. · May 1986
RMI POROUS VENT PLUG
K861322 · Research Medical, Inc. · May 1986
CHEST DRAINAGE PACK, CDP-1000
K861103 · Gish Biomedical, Inc. · May 1986
TORAY ANTHRON BYPASS TUBES
K861116 · Toray Industries (America), Inc. · May 1986
STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA
K861496 · Shiley, Inc. · May 1986