Cleared Traditional

K860867 - DIGITAL SUBTRACTION ANGIOGRAPHY CATHETE...

K860867 is an FDA 510(k) clearance for DIGITAL SUBTRACTION ANGIOGRAPHY CATHETE..., manufactured by Medical Components, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K860867 · Medical Components, Inc. · Cardiovascular device
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Jul 1986
Decision
117d
Days
Class 2
Risk

K860867 is an FDA 510(k) clearance for the DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on July 2, 1986 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Medical Components, Inc. devices

FDA 510(k) Submission Details - K860867

510(k) Number K860867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1986
Decision Date July 02, 1986
Days to Decision 117 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
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 319
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K860867.
SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK
K862465 · Shiley, Inc. · Aug 1986
ANGIOFLOW
K854910 · Angiomed U.S., Inc. · Jul 1986
ACS CORONARY GUIDING CATHETER
K861236 · Advanced Cardiovascular Systems, Inc. · Jul 1986
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
K862006 · Cordis Corp. · Jun 1986
ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)
K861483 · Mallinckrodt Critical Care · May 1986
PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337
K860805 · Gould, Inc. · May 1986