NKUClass II

Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed

Cardiovascular · 21 CFR 870.1650

MDR events0All time

Recalls1All time

Registered firms0Currently listed

510(k) clearances1All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Sterilmed Inc
TerminatedJan 13, 2009
Balloon Inflation Device
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
Z-0546-2009 · View FDA record ↗

Registered firms

0 firms currently registered for this product code

No registered firms found for this product code.

510(k) clearances

1 clearances for this product code

Sterilmed, Inc.May 4, 2006
K053188 · REPROCESSED BALOON INFLATION DEVICE