PMT VASCULAR CATHETER MODEL NUMBER 3621-1— 510(k) K883313

Substantially Equivalent

Pmt Corp.

FDA 510(k) clearance K883313 for PMT VASCULAR CATHETER MODEL NUMBER 3621-1, Substantially Equivalent on 1988-10-04. Applicant: Pmt Corp..

Clearance details

Applicant: Pmt Corp.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 1988-08-05
Decision date: 1988-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chanhassen, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.