CPI MODEL 2215/SEAMED MODEL 3400— 510(k) K910223

Substantially Equivalent

Seamed Corp.

FDA 510(k) clearance K910223 for CPI MODEL 2215/SEAMED MODEL 3400, Substantially Equivalent on 1991-03-19. Applicant: Seamed Corp..

Clearance details

Applicant: Seamed Corp.
Product code: Code DTC
Advisory panel: Cardiovascular
Date received: 1991-01-18
Decision date: 1991-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

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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.