Cleared Traditional

K885179 - INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD

K885179 is an FDA 510(k) clearance for INTRO-FLEX SHEATH INTRODUCER W/AMC THRO..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K885179 · Baxter Healthcare Corp · Cardiovascular device
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Aug 1989
Decision
238d
Days
Class 2
Risk

K885179 is an FDA 510(k) clearance for the INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on August 9, 1989 after a review of 238 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K885179

510(k) Number K885179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1988
Decision Date August 09, 1989
Days to Decision 238 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 125d · This submission: 238d
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 609
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K885179.
DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO
K894343 · Daig Corp. · Sep 1989
CATHETER INTRODUCER SHEATH
K890766 · Applied Vascular Devices, Inc. · Sep 1989
MODIFIED LABELING TO PERMANENT LEAD INTRODUCER
K894431 · Daig Corp. · Sep 1989
MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY
K894430 · Daig Corp. · Aug 1989
PERCUTANEOUS INTRODUCER
K893658 · Medamicus, Inc. · Aug 1989
INTRODUCER FOR PTCA GUIDING CATHETERS
K891022 · Argon Medical Corp. · May 1989