← Product Code [LRS](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LRS) · K001879

# INFUSION IV SET (K001879)

_Nirvi Intl. USA · LRS · Nov 20, 2001 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LRS/K001879

## Device Facts

- **Applicant:** Nirvi Intl. USA
- **Product Code:** [LRS](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LRS.md)
- **Decision Date:** Nov 20, 2001
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LRS/K001879](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LRS/K001879)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com