Cleared Traditional

K012983 - ACIST 4 FRENCH ANGIOGRAPHIC CATHETER

K012983 is an FDA 510(k) clearance for ACIST 4 FRENCH ANGIOGRAPHIC CATHETER, manufactured by Acist Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K012983 · Acist Medical Systems, Inc. · Cardiovascular device
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Mar 2002
Decision
189d
Days
Class 2
Risk

K012983 is an FDA 510(k) clearance for the ACIST 4 FRENCH ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on March 13, 2002 after a review of 189 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Acist Medical Systems, Inc. devices

FDA 510(k) Submission Details - K012983

510(k) Number K012983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2001
Decision Date March 13, 2002
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 125d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 371
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K012983.
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CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR
K020316 · Cordis Corp. · Mar 2002
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K014054 · Edwards Lifesciences, LLC · Mar 2002
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
K003086 · Concentric Medical, Inc. · May 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
K011217 · Abbott Laboratories · May 2001