← Product Code [DWP](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP) · K910682

# ROBICSEK PROBE/RETRACTOR (K910682)

_Bio-Vascular, Inc. · DWP · May 8, 1991 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K910682

## Device Facts

- **Applicant:** Bio-Vascular, Inc.
- **Product Code:** [DWP](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP.md)
- **Decision Date:** May 8, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4475
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A surgical vessel dilator is a device used to enlarge or calibrate a vessel.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K910682](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K910682)

**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
