Cleared Traditional

K873195 - SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO

K873195 is an FDA 510(k) clearance for SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INT..., manufactured by Angiomedics, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K873195 · Angiomedics, Inc. · Cardiovascular device
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Dec 1987
Decision
123d
Days
Class 2
Risk

K873195 is an FDA 510(k) clearance for the SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Angiomedics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 15, 1987 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Angiomedics, Inc. devices

FDA 510(k) Submission Details - K873195

510(k) Number K873195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1987
Decision Date December 15, 1987
Days to Decision 123 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 125d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 645
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K873195.
OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE
K882221 · Argon Medical Corp. · Aug 1988
ACS FUNNEL INTRODUCER
K875158 · Advanced Cardiovascular Systems, Inc. · May 1988
OLYMPUS ANGIOSCOPY SHEATH
K873100 · Olympus Corp. · Feb 1988
PULL-APART INTRODUCER (SHEATH)
K873727 · Quinton, Inc. · Oct 1987
OVAL PULL-APART SHEATH/DILATOR
K873394 · Quinton, Inc. · Sep 1987
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M
K871208 · Pacesetter Systems · Jun 1987