← Product Code [DXO](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO) · K935166

# FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER (K935166)

_Millar Instruments, Inc. · DXO · Aug 5, 1994 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K935166

## Device Facts

- **Applicant:** Millar Instruments, Inc.
- **Product Code:** [DXO](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO.md)
- **Decision Date:** Aug 5, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2870
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K935166](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K935166)

**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
