← Product Code [DWP](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP) · K891786

# PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) (K891786)

_Pioneering Technologies, Inc. · DWP · Oct 12, 1989 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K891786

## Device Facts

- **Applicant:** Pioneering Technologies, Inc.
- **Product Code:** [DWP](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP.md)
- **Decision Date:** Oct 12, 1989
- **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.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K891786](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K891786)

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