← Product Code [FOZ](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ) · 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) (K252513)

_Poly Medicure Limited · FOZ · Apr 1, 2026 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K252513

## Device Facts

- **Applicant:** Poly Medicure Limited
- **Product Code:** [FOZ](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ.md)
- **Decision Date:** Apr 1, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 880.5200
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K252513](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K252513)

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