← Product Code [MJN](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN) · K001237

# EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO (K001237)

_Micro Therapeutics, Inc. · MJN · May 18, 2000 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K001237

## Device Facts

- **Applicant:** Micro Therapeutics, Inc.
- **Product Code:** [MJN](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN.md)
- **Decision Date:** May 18, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.4450
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K001237](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K001237)

**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