Cleared Traditional

K875158 - ACS FUNNEL INTRODUCER

K875158 is an FDA 510(k) clearance for ACS FUNNEL INTRODUCER, manufactured by Advanced Cardiovascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K875158 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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May 1988
Decision
168d
Days
Class 2
Risk

K875158 is an FDA 510(k) clearance for the ACS FUNNEL INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Temecula, US). The FDA issued a Cleared decision on May 31, 1988 after a review of 168 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.

FDA 510(k) Submission Details - K875158

510(k) Number K875158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1987
Decision Date May 31, 1988
Days to Decision 168 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
43d slower than avg
Panel avg: 125d · This submission: 168d
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 706
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K875158.
INTRODUCING CATHETER
K883933 · Devices For Vascular Intervention, Inc. · Dec 1988
MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH
K881825 · Spectramed, Inc. · Sep 1988
OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE
K882221 · Argon Medical Corp. · Aug 1988
OLYMPUS ANGIOSCOPY SHEATH
K873100 · Olympus Corp. · Feb 1988
SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO
K873195 · Angiomedics, Inc. · Dec 1987
PULL-APART INTRODUCER (SHEATH)
K873727 · Quinton, Inc. · Oct 1987
K875158 · ACS FUNNEL INTRODUCER
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