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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances
  • 510(k)K123378Substantially equivalent (SESE) · 2012-11-30clearance family

Predicate lineage

K123378

Cited as predicate by: K141491, K153071, K162539

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2021-09-17VAIVoluntary action indicatedMicro Therapeutics, Inc.0
2015-07-17VAIVoluntary action indicatedMicro Therapeutics, Inc.1
2015-03-26NAINo action indicatedMicro Therapeutics, Inc.0
2013-03-27NAINo action indicatedMicro Therapeutics, Inc.0
2012-01-09NAINo action indicatedMicro Therapeutics, Inc.0
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