Cleared Special

K000013 - ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000

K000013 is an FDA 510(k) clearance for ACIST ANGIOGRAPHIC INJECTION SYSTEM, manufactured by Acist Medical Systems. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Special 510(k) pathway after a 85-day FDA review.

K000013 · Acist Medical Systems · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
85d
Days
Class 2
Risk

K000013 is an FDA 510(k) clearance for the ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Acist Medical Systems (Eden Prairie, US). The FDA issued a Cleared decision on March 28, 2000 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K000013

510(k) Number K000013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2000
Decision Date March 28, 2000
Days to Decision 85 days
Submission Type Special
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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 184
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K000013.
FRONT-LOAD POLYPROPYLENE SYRINGE
K001663 · Medrad, Inc. · Nov 2000
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
K984231 · Invasatec · May 2000
MODIFICATION TO ACIST CL 100H
K991103 · Acist Medical Systems · May 2000
3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
K983826 · Unimachs Corp. · Mar 2000
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
K993774 · Acist Medical Systems · Dec 1999
OPTISTAR MR INJECTOR SYSTEM
K984088 · Mallinckrodt Inc., Liebel-Flarsheim Business · Dec 1999