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

Name: FDA 510(k) clearance K910223
Creator: U.S. Food and Drug Administration
Published: 1991-03-19

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.. Device class: 2.

Clearance details

Applicant: Seamed Corp.
Product code: Code DTC
Device class: Class 2
Regulation: 21 CFR 870.3630
Advisory panel: Cardiovascular
Date received: 1991-01-18
Decision date: 1991-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Seamed Corp.

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K923398 — CPI MODEL 22151992-08-14
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K912507 — CPI MODEL 2215 & SEAMED MODEL 34001991-09-03
K883930 — SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY1988-11-09
K872551 — SEAMED MODEL 32001987-07-31

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.