← Product Code [FOZ](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ) · K001616

# MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE (K001616)

_Abbott Laboratories · FOZ · Jul 27, 2000 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K001616

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [FOZ](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ.md)
- **Decision Date:** Jul 27, 2000
- **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/K001616](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K001616)

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