FDA Registration
Active
🇺🇸 United States
PICCOLO MEDICAL, INC.
Reg #: 3038181770
·
FEI: 3038181770
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
4
Classifications
4
Registration Details
- Registration Name
- PICCOLO MEDICAL, INC.
- Registration Number
- 3038181770
- FEI Number
- 3038181770
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 218 Mississippi St
- City
- San Francisco
- State
- CA
- ZIP
- 94107
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243484
Owner / Operator
- Firm Name
- Piccolo Medical, Inc.
- Operator Number
- 10093237
- Address
- 218 Mississippi St
- City
- San Francisco
- State
- CA
- Postal Code
- 94107
- Country
- US
- Correspondent
- Augustus Shanahan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2025-11-17 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2025-11-17 |
| Saline, Vascular Access Flush | NGT | Class 2 | General Hospital | No | 2025-11-17 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2025-11-17 |
Proprietary Names
PM2+ System
Nav+ Guidance Set
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device