Cleared Traditional

K854910 - ANGIOFLOW

K854910 is the FDA 510(k) clearance for ANGIOFLOW by Angiomed U.S., Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K854910 · Angiomed U.S., Inc. · Cardiovascular device
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Jul 1986
Decision
220d
Days
Class 2
Risk

K854910 is an FDA 510(k) clearance for the ANGIOFLOW. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Angiomed U.S., Inc. (Anaheim, US). The FDA issued a Cleared decision on July 17, 1986 after a review of 220 days - an extended review cycle.

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 Angiomed U.S., Inc. devices

Submission Details

510(k) Number K854910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1985
Decision Date July 17, 1986
Days to Decision 220 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 125d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 292
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K854910.
SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR
K862464 · Shiley, Inc. · Aug 1986
MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS
K862244 · Cordis Corp. · Aug 1986
SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK
K862465 · Shiley, Inc. · Aug 1986
ACS CORONARY GUIDING CATHETER
K861236 · Advanced Cardiovascular Systems, Inc. · Jul 1986
DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS
K860867 · Medical Components, Inc. · Jul 1986
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
K862006 · Cordis Corp. · Jun 1986