← Product Code [KRK](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK) · K884386

# ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK (K884386)

_Ethitek Pharmaceuticals Co. · KRK · Jan 5, 1989 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK/K884386

## Device Facts

- **Applicant:** Ethitek Pharmaceuticals Co.
- **Product Code:** [KRK](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK.md)
- **Decision Date:** Jan 5, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1140
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK/K884386](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK/K884386)

**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