Cleared Traditional

DISPOSABLE VASCULAR ANGIOSCOPE (K914570) - FDA 510(k) Clearance

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

K914570 · Nobles-Lai · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
104d
Days
Class 2
Risk

K914570 is an FDA 510(k) clearance for the DISPOSABLE VASCULAR ANGIOSCOPE. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Nobles-Lai (Costa Mesa, US). The FDA issued a Cleared decision on January 27, 1992 after a review of 104 days - within the typical 510(k) review window.

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 Nobles-Lai devices

Submission Details

510(k) Number K914570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1991
Decision Date January 27, 1992
Days to Decision 104 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 125d · This submission: 104d
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 10
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K914570.
KSEA VASCULAR FIBERSCOPES
K001408 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
K964061 · W.L. Gore & Associates, Inc. · Feb 1997
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
OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE
K860858 · Olympus Corp. · Nov 1986