Cleared Traditional

K890766 - CATHETER INTRODUCER SHEATH

K890766 is an FDA 510(k) clearance for CATHETER INTRODUCER SHEATH, manufactured by Applied Vascular Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K890766 · Applied Vascular Devices, Inc. · Cardiovascular device
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Sep 1989
Decision
215d
Days
Class 2
Risk

K890766 is an FDA 510(k) clearance for the CATHETER INTRODUCER SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Applied Vascular Devices, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on September 18, 1989 after a review of 215 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 Applied Vascular Devices, Inc. devices

FDA 510(k) Submission Details - K890766

510(k) Number K890766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1989
Decision Date September 18, 1989
Days to Decision 215 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
90d slower than avg
Panel avg: 125d · This submission: 215d
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 603
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K890766.
HEMOSTASIS VALVE
K895214 · Applied Vascular Devices, Inc. · Nov 1989
OBTURATOR
K894157 · Argon Medical Corp. · Sep 1989
DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO
K894343 · Daig Corp. · Sep 1989
MODIFIED LABELING TO PERMANENT LEAD INTRODUCER
K894431 · Daig Corp. · Sep 1989
INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD
K885179 · Baxter Healthcare Corp · Aug 1989
MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY
K894430 · Daig Corp. · Aug 1989