Cleared Traditional

K861847 - ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE

K861847 is the FDA 510(k) clearance for ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code LOX) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K861847 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Jun 1986
Decision
34d
Days
Class 2
Risk

K861847 is an FDA 510(k) clearance for the ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Temecula, US). The FDA issued a Cleared decision on June 16, 1986 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - 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 K861847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1986
Decision Date June 16, 1986
Days to Decision 34 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
91d faster than avg
Panel avg: 125d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.
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 - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 47
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K861847.
NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
K121667 · Boston Scientific Corp · Aug 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
K113220 · Boston Scientific Corporation · Mar 2012
THE PILOT SCIMED TORQUE DEVICE
K896108 · Scimed Life Systems, Inc. · Jan 1990
PTCA BALLOON CATHETERS & ACCESSORIES
K843944 · Advanced Cardiovascular Systems, Inc. · Feb 1985