Certa Catheter— 510(k) K171193
Substantially EquivalentFerrosan Medical Devices Sp. Z.O.O.
FDA 510(k) clearance K171193 for Certa Catheter, Substantially Equivalent on 2017-12-18. Applicant: Ferrosan Medical Devices Sp. Z.O.O..
Clearance details
- Applicant
- Ferrosan Medical Devices Sp. Z.O.O.
- Product code
- Code BSO
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Szczecin, PL
Adverse events under product code BSO
product code BSO- Malfunction
- 688
- Total
- 688
Source: openFDA MAUDE database, through . 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.