Angiographic Contrast Management System, Model Part a and Part B

510(k) K984231

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK984231	Date31 May 2000Cleared	StatusActive

4 recalls · FDA

- Terminated Z-0744-2016 FDA Class II initiated 21 Dec 2015
Reports related to ingress of air into the manifold.
- Terminated Z-0359-2008 FDA Unclassified (pre-2012) initiated 3 Oct 2007
Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture.
- Terminated Z-1002-04 FDA Unclassified (pre-2012) initiated 19 May 2004
Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
- Terminated Z-0064-04 FDA Unclassified (pre-2012) initiated 2 Oct 2003
Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak.

1 jurisdiction

United States — FDA 510(k) Active

510(k)