K231401 is an FDA 510(k) clearance for the Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Poly Medicure Limited (Faridabad, IN). The FDA issued a Cleared decision on September 21, 2023, 129 days after receiving the submission on May 15, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K231401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2023 |
| Decision Date | September 21, 2023 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ - Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |