PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT— 510(k) K883221

Substantially Equivalent

Pioneering Technologies, Inc.

FDA 510(k) clearance K883221 for PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT, Substantially Equivalent on 1988-10-13. Applicant: Pioneering Technologies, Inc..

Clearance details

Applicant: Pioneering Technologies, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1988-07-29
Decision date: 1988-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.