Cleared Traditional

K851854 - ADVANCED CARDIOVASCULAR SYS LOW PROFILE...

K851854 is the FDA 510(k) clearance for ADVANCED CARDIOVASCULAR SYS LOW PROFILE... by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K851854 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Aug 1985
Decision
101d
Days
Class 2
Risk

K851854 is an FDA 510(k) clearance for the ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 5, 1985 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K851854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date August 05, 1985
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 243
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K851854.
SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER
K854319 · Shiley, Inc. · Mar 1986
ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO
K853746 · Advanced Cardiovascular Systems, Inc. · Oct 1985
CORDIS PTA CATHETER-PERCUTANEOUS CATHETER
K844913 · Cordis Corp. · Aug 1985
ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER
K844972 · Advanced Cardiovascular Systems, Inc. · May 1985
SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT
K850075 · Scimed Life Systems, Inc. · Apr 1985
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER
K850760 · Scimed Life Systems, Inc. · Apr 1985