Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
FDA 510(k) K231401 · Poly Medicure Limited
510(k) numberK231401
Submission
- Device name
- Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
- Applicant
- Poly Medicure Limited
Faridabad, IN - Received
- May 15, 2023
- Decision date
- September 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Other 510(k)s with product code FOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K261041 | ClearSafe Closed SystemFOZ · Traditional | MedSource Labs, LLC | 07/10/2026SE |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional | MedSource Labs, LLC | 07/09/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | B.Braun Medical, Inc. | 05/15/2026SE |
| K252137 | BD Insyte IV CatheterFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 04/02/2026SE |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | Poly Medicure Limited | 04/01/2026SE |
| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
| K252677 | Polyshield Safety IV CathetersFOZ · Special | Poly Medicure Limited | 11/05/2025SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
More from Becton Dickinson Infusion Therapy Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | 04/01/2026SE |
| K252677 | Polyshield Safety IV CathetersFOZ · Special | 11/05/2025SE |
| K232234 | Nouvo Safety SetFOZ · Traditional | 03/15/2024SE |
| K230616 | Polyguard and Polyshield Safety IV CathetersFOZ · Traditional | 05/05/2023SE |
| K220312 | Polyfusion IV Administration SetsFPA · Traditional | 04/12/2023SE |
Questions and answers
When was Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva cleared by the FDA?
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva (K231401) received a 510(k) decision of Substantially Equivalent on September 21, 2023, 129 days after the submission was received.
What is the product code of K231401?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.