PAINFUSOR CATHETER— 510(k) K111031

Substantially Equivalent

Plan 1 Health, S.R.L.

FDA 510(k) clearance K111031 for PAINFUSOR CATHETER, Substantially Equivalent on 2011-07-08. Applicant: Plan 1 Health, S.R.L..

Clearance details

Applicant: Plan 1 Health, S.R.L.
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2011-04-14
Decision date: 2011-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palos Verdes Estates, CA, US

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Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.