Cleared Traditional

K890047 - VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIV...

K890047 is the FDA 510(k) clearance for VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIV... by Vascucare, Inc.. It is a Class 2 Cardiovascular device (product code LYK) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K890047 · Vascucare, Inc. · Cardiovascular device
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Jun 1989
Decision
166d
Days
Class 2
Risk

K890047 is an FDA 510(k) clearance for the VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Vascucare, Inc. (Orangeburg, US). The FDA issued a Cleared decision on June 20, 1989 after a review of 166 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 876.1500 - 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 Vascucare, Inc. devices

Submission Details

510(k) Number K890047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1989
Decision Date June 20, 1989
Days to Decision 166 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 125d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LYK Angioscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - LYK Angioscope

All 15
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K890047.
BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE
K931464 · Baxter Healthcare Corp · Oct 1993
OLYMPUS AF ANGIOSCOPE SYSTEM
K911278 · Olympus Corp. · Jul 1991
4.5F IMAGECATH ANGIOSCOPE
K905083 · Baxter Healthcare Corp · Jun 1991
ACS ANGIOSCOPE GUIDE WIRE
K883000 · Advanced Cardiovascular Systems, Inc. · Sep 1988
ACS CORONARY ANGIOSCOPIC CATHETER
K875108 · Advanced Cardiovascular Systems, Inc. · Sep 1988
OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE
K860858 · Olympus Corp. · Nov 1986