FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Primero Safe Access System
K Number: K252441
·
Decision Sep 29, 2025
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
1
Review Days
56
Basic Information
- Device Name
- Primero Safe Access System
- K Number
- K252441
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- South53, LLC
- Date Received
- August 4, 2025
- Decision Date
- September 29, 2025
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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