DeviceClearance

K232258

Substantially Equivalent

XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter

Applicant
Transit Scientific, LLC
Product code
PNO
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Salt Lake City, UT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code PNO

product code PNO
Malfunction
1,646
Total
1,646

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.