Cleared Traditional

K854261 - ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTA...

K854261 is the FDA 510(k) clearance for ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTA... by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K854261 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Dec 1985
Decision
42d
Days
Class 2
Risk

K854261 is an FDA 510(k) clearance for the ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on December 4, 1985 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K854261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1985
Decision Date December 04, 1985
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 69
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K854261.
DISPOSABLE MANIFOLD
K854960 · Utah Medical Products, Inc. · Feb 1986
HEMOSTATIC SIDEARM
K854397 · Target Therapeutics · Jan 1986
ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL
K853950 · American Bentley · Dec 1985
PRESSURE SENSING SYRINGE 65000
K853586 · Dlp, Inc. · Nov 1985
CAPIOX BLOOD SAMPLING MANIFOLD
K852086 · Terumo Medical Corp. · Aug 1985
FILTER PURGE LINE EC-FPL SERIES
K833644 · Gish Biomedical, Inc. · Dec 1984