← Product Code [OWQ](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ) · K012537

# REPROCESSED IMAGING CATHETERS (K012537)

_Sterilmed, Inc. · OWQ · Oct 11, 2002 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K012537

## Device Facts

- **Applicant:** Sterilmed, Inc.
- **Product Code:** [OWQ](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ.md)
- **Decision Date:** Oct 11, 2002
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1200
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K012537](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K012537)

**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