← Product Code [DRC](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC) · K011349

# INTERCOSTAL LOCKABLE-DIRECTABLE PORT (K011349)

_Medcanica, Inc. · DRC · Oct 5, 2001 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K011349

## Device Facts

- **Applicant:** Medcanica, Inc.
- **Product Code:** [DRC](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC.md)
- **Decision Date:** Oct 5, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1390
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

## Special Controls

*Classification.* Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K011349](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K011349)

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