Data / Medical devices / United States / Piccolo Medical
Piccolo Medical: FDA-registered device maker in San Francisco, CA, United States, 2 510(k) clearances
Piccolo Medical is registered with the FDA (registration 3038181770) in San Francisco, CA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 17, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3038181770
- Address
- 218 Mississippi St, San Francisco, CA, United States, 94107
- Owner or operator
- Spectrum Vascular (10090343)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 11, 2026
- Registered through
- 2026
- Brand names listed
- ECGuide Bundle Pack, ECGuide Connector, Nav+ Guidance Set, PM2 System, PM2+ System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Saline, Vascular Access Flush | NGT | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 17, 2025 | K252792 | PM2 System with ECGuide Connector | LJS | Substantially Equivalent | Piccolo Medical, Inc. | accessdata.fda.gov |
| May 29, 2025 | K243484 | PM2+ System and SmartPICC Stylet | LJS | Substantially Equivalent | Piccolo Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Electrocardiograph
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- All makers of Saline, Vascular Access Flush
Updated November 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.