Cleared Traditional

INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD (K885179) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 216
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K885179.
HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS
K897041 · C.R. Bard, Inc. · Mar 1990
DUAL GUIDE INTRODUCER CATHETER
K895044 · Cook, Inc. · Feb 1990
MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM
K891121 · Boston Scientific Corp · Dec 1989
USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR
K884104 · C.R. Bard, Inc. · Dec 1988
CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST
K861082 · Cordis Corp. · May 1986
CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES
K855126 · Cordis Corp. · Feb 1986