Cleared Traditional

K894496 - OLYMPUS VALVULOTOME W/FIXED TIP

K894496 is an FDA 510(k) clearance for OLYMPUS VALVULOTOME W/FIXED TIP, manufactured by Olympus Corp.. The device is a Class 2 Cardiovascular device with product code DWX cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K894496 · Olympus Corp. · Cardiovascular device
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Oct 1989
Decision
85d
Days
Class 2
Risk

K894496 is an FDA 510(k) clearance for the OLYMPUS VALVULOTOME W/FIXED TIP. Classified as Stripper, Artery, Intraluminal (product code DWX), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on October 12, 1989 after a review of 85 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 Olympus Corp. devices

FDA 510(k) Submission Details - K894496

510(k) Number K894496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1989
Decision Date October 12, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
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 K894496.
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
SCANLAN ENDARSECTOR
K841521 · Scanlan Intl., Inc. · Aug 1984
HALL ARTERIAL OSCILLATOR
K801063 · American Sterilizer Co. · Sep 1980