PCEA Syringe Set— 510(k) K211649
Substantially EquivalentBaxter Healthcare Corporation
FDA 510(k) clearance K211649 for PCEA Syringe Set, Substantially Equivalent on 2021-11-23. Applicant: Baxter Healthcare Corporation.
Clearance details
- Applicant
- Baxter Healthcare Corporation
- Product code
- Code PWH
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Lake, IL, US
Adverse events under product code PWH
product code PWH- Other
- 1
- Total
- 1
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.