PM2+ System and SmartPICC Stylet— 510(k) K243484
Substantially EquivalentPiccolo Medical, Inc.
FDA 510(k) clearance K243484 for PM2+ System and SmartPICC Stylet, Substantially Equivalent on 2025-05-29. Applicant: Piccolo Medical, Inc..
Clearance details
- Applicant
- Piccolo Medical, Inc.
- Product code
- Code LJS
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Adverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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.