K882879

Substantially Equivalent

PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)

Applicant: Pioneering Technologies, Inc.
Product code: DXC
Advisory panel: Cardiovascular
Date received: 1988-07-11
Decision date: 1988-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.