P POLYMER— 510(k) K893990

Substantially Equivalent

Pace West

FDA 510(k) clearance K893990 for P POLYMER, Substantially Equivalent on 1989-10-12. Applicant: Pace West.

Clearance details

Applicant: Pace West
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1989-06-05
Decision date: 1989-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.