Cleared Traditional

K873100 - OLYMPUS ANGIOSCOPY SHEATH

K873100 is an FDA 510(k) clearance for OLYMPUS ANGIOSCOPY SHEATH, manufactured by Olympus Corp.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K873100 · Olympus Corp. · Cardiovascular device
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Feb 1988
Decision
206d
Days
Class 2
Risk

K873100 is an FDA 510(k) clearance for the OLYMPUS ANGIOSCOPY SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on February 29, 1988 after a review of 206 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Olympus Corp. devices

FDA 510(k) Submission Details - K873100

510(k) Number K873100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1987
Decision Date February 29, 1988
Days to Decision 206 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
81d slower than avg
Panel avg: 125d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 409
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K873100.
USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR
K884104 · C.R. Bard, Inc. · Dec 1988
OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE
K882221 · Argon Medical Corp. · Aug 1988
ACS FUNNEL INTRODUCER
K875158 · Advanced Cardiovascular Systems, Inc. · May 1988
PULL-APART INTRODUCER (SHEATH)
K873727 · Quinton, Inc. · Oct 1987
OVAL PULL-APART SHEATH/DILATOR
K873394 · Quinton, Inc. · Sep 1987
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M
K871208 · Pacesetter Systems · Jun 1987