← Product Code [FOS](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOS) · K954300

# ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY (K954300)

_Sherwood Medical Co. · FOS · Dec 13, 1995 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOS/K954300

## Device Facts

- **Applicant:** Sherwood Medical Co.
- **Product Code:** [FOS](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOS.md)
- **Decision Date:** Dec 13, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **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/FOS/K954300](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOS/K954300)

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