← Product Code [KRA](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA) · K010004

# FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 (K010004)

_Micro Therapeutics, Inc. · KRA · Feb 13, 2001 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K010004

## Device Facts

- **Applicant:** Micro Therapeutics, Inc.
- **Product Code:** [KRA](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA.md)
- **Decision Date:** Feb 13, 2001
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.1210
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K010004](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K010004)

**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