DeviceClearance

K990829

Substantially Equivalent

ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65

Applicant
Arrow Intl., Inc.
Product code
MCW
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Reading, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MCW

product code MCW
Death
38
Injury
1,386
Malfunction
2,676
Other
2
Total
4,102

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.