Cleared Traditional

K895878 - OLYMPUS VALVULOTOME W/DETACHABLE TIP

K895878 is the FDA 510(k) clearance for OLYMPUS VALVULOTOME W/DETACHABLE TIP by Olympus Corp.. It is a Class 2 Cardiovascular device (product code DWX) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K895878 · Olympus Corp. · Cardiovascular device
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Jan 1990
Decision
89d
Days
Class 2
Risk

K895878 is an FDA 510(k) clearance for the OLYMPUS VALVULOTOME W/DETACHABLE 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 January 2, 1990 after a review of 89 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

Submission Details

510(k) Number K895878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1989
Decision Date January 02, 1990
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (DWX) and FDA review panel - the closest regulatory comparables to K895878.
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/FIXED TIP
K894496 · Olympus Corp. · Oct 1989
HALL ARTERIAL OSCILLATOR
K801063 · American Sterilizer Co. · Sep 1980