TAKY-SPIKE PLUS— 510(k) K974198

Substantially Equivalent

Clinico

FDA 510(k) clearance K974198 for TAKY-SPIKE PLUS, Substantially Equivalent on 1997-12-22. Applicant: Clinico.

Clearance details

Applicant: Clinico
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1997-11-10
Decision date: 1997-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bad Hersfeld, DE

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.