Cleared Traditional

K003719 - VASCULAR ARCHITECTS PERISCOPE DEVICE

K003719 is an FDA 510(k) clearance for VASCULAR ARCHITECTS PERISCOPE DEVICE, manufactured by Vascular Architects, Inc.. The device is a Class 2 Cardiovascular device with product code DWX cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K003719 · Vascular Architects, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
86d
Days
Class 2
Risk

K003719 is an FDA 510(k) clearance for the VASCULAR ARCHITECTS PERISCOPE DEVICE. Classified as Stripper, Artery, Intraluminal (product code DWX), Class II - Special Controls.

Submitted by Vascular Architects, Inc. (San Jose, US). The FDA issued a Cleared decision on February 28, 2001 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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 Vascular Architects, Inc. devices

FDA 510(k) Submission Details - K003719

510(k) Number K003719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2000
Decision Date February 28, 2001
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWX Device Classification - Class 2, Special Controls

Product Code DWX Stripper, Artery, Intraluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
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 - DWX Stripper, Artery, Intraluminal

All 7
Devices cleared under the same product code (DWX) and FDA review panel - the closest regulatory comparables to K003719.
MOLLRING MULTITASC
K121415 · LeMaitre Vascular, Inc. · Sep 2012
EXTERNAL VEIN STRIPPER
K933498 · Applied Medical Resources · Mar 1994
MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE
K911099 · Pilling Co. · Jun 1991
TRANSLUMINAL ENDARTERECTOMY DEVICE
K904944 · Baxter Healthcare Corp · Dec 1990
OLYMPUS VALVULOTOME W/DETACHABLE TIP
K895878 · Olympus Corp. · Jan 1990
OLYMPUS VALVULOTOME W/FIXED TIP
K894496 · Olympus Corp. · Oct 1989