Cleared Traditional

K885179 - INTRO-FLEX SHEATH INTRODUCER W/AMC THRO...

K885179 is the FDA 510(k) clearance for INTRO-FLEX SHEATH INTRODUCER W/AMC THRO... by Baxter Healthcare Corp. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 395
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K885179.
MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM
K891121 · Boston Scientific Corp · Dec 1989
DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO
K894343 · Daig Corp. · 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
HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT
K890277 · Oscor Medical Corp. · Mar 1989
DAIG OBTURATOR, CATHETER INTRODUCER
K884494 · Daig Corp. · Feb 1989