FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)
K Number: K252513
·
Decision Apr 1, 2026
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
6
Review Days
233
Basic Information
- Device Name
- Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)
- K Number
- K252513
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Poly Medicure Limited
- Date Received
- August 11, 2025
- Decision Date
- April 1, 2026
- Product Code
- FOZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by Poly Medicure Limited
| K Number | Device Name | ||
|---|---|---|---|
| K252677 | Polyshield Safety IV Catheters | Nov 5, 2025 | Substantially Equivalent |
| K232234 | Nouvo Safety Set | Mar 15, 2024 | Substantially Equivalent |
| K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva | Sep 21, 2023 | Substantially Equivalent |
| K230616 | Polyguard and Polyshield Safety IV Catheters | May 5, 2023 | Substantially Equivalent |
| K220312 | Polyfusion IV Administration Sets | Apr 12, 2023 | Substantially Equivalent |