K252513

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)

510(k) number: K252513
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)
Applicant: Poly Medicure Limited IN
Product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
Decision date: 2026-04-01
Date received: 2025-08-11
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: General Hospital

PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain

Also available from FDA: K252513.pdf

Official FDA record: K252513

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.