Cleared Traditional

K984231 - ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B

K984231 is an FDA 510(k) clearance for ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, manufactured by Invasatec. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 553-day FDA review.

K984231 · Invasatec · Cardiovascular device
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May 2000
Decision
553d
Days
Class 2
Risk

K984231 is an FDA 510(k) clearance for the ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Invasatec (Eden Prairie, US). The FDA issued a Cleared decision on May 31, 2000 after a review of 553 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Invasatec devices

FDA 510(k) Submission Details - K984231

510(k) Number K984231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1998
Decision Date May 31, 2000
Days to Decision 553 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
428d slower than avg
Panel avg: 125d · This submission: 553d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 128
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K984231.
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
K011991 · Medrad, Inc. · Aug 2001
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
K010390 · Acist Medical Systems, Inc. · Mar 2001
FRONT-LOAD POLYPROPYLENE SYRINGE
K001663 · Medrad, Inc. · Nov 2000
3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
K983826 · Unimachs Corp. · Mar 2000
OPTISTAR MR INJECTOR SYSTEM
K984088 · Mallinckrodt Inc., Liebel-Flarsheim Business · Dec 1999
MEDRAD ENVISION CT INJECTOR SYSTEM
K993728 · Medrad, Inc. · Nov 1999