Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1390](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1390) → NMK — Trocar, Reprocessed

# NMK · Trocar, Reprocessed

_Cardiovascular · 21 CFR 870.1390 · Class 2_

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

## Overview

- **Product Code:** NMK
- **Device Name:** Trocar, Reprocessed
- **Regulation:** [21 CFR 870.1390](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1390)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

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

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K192998](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NMK/K192998.md) | Reprocessed BRK Transseptal Needle | Innovative Health, LLC | Jul 22, 2020 | SESE |

## Top Applicants

- Innovative Health, LLC — 1 clearance

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

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