Cleared Traditional

POLY-TECH ANGIOGRAPHY CATHETER (K862030) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862030 · Poly-Tech Medical Device Research & Development · Cardiovascular device
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Aug 1986
Decision
72d
Days
Class 2
Risk

K862030 is an FDA 510(k) clearance for the POLY-TECH ANGIOGRAPHY CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Poly-Tech Medical Device Research & Development (Alvin, US). The FDA issued a Cleared decision on August 8, 1986 after a review of 72 days - a notably fast clearance 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: 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 Poly-Tech Medical Device Research & Development devices

Submission Details

510(k) Number K862030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1986
Decision Date August 08, 1986
Days to Decision 72 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 125d · This submission: 72d
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 156
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K862030.
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
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
K862006 · Cordis Corp. · Jun 1986
MODIFIED CORDIS PTCA GUIDING CATHETERS
K854576 · Cordis Corp. · Feb 1986
PTCA GUIDING CATHER
K844161 · Cordis Corp. · Jan 1985