SEAMED MODEL 3000— 510(k) K860462

Substantially Equivalent

Seamed Corp.

FDA 510(k) clearance K860462 for SEAMED MODEL 3000, Substantially Equivalent on 1986-08-19. Applicant: Seamed Corp..

Clearance details

Applicant: Seamed Corp.
Product code: Code DTC
Advisory panel: Cardiovascular
Date received: 1986-02-06
Decision date: 1986-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTC

product code DTC

Injury: 136
Malfunction: 3,400
Total: 3,536

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.