INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET— 510(k) K001329

Substantially Equivalent

Lifemed of California

FDA 510(k) clearance K001329 for INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET, Substantially Equivalent on 2001-02-14. Applicant: Lifemed of California.

Clearance details

Applicant: Lifemed of California
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2000-04-27
Decision date: 2001-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.