Skip to content

Namic Cournand Style Introducer Needle

by North American Instrument Corp.

510(k) K871377

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871377 Date7 May 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRC
Device Class
Class II
Regulation
21 CFR Part 870.1390
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Namic Cournand Style Introducer Needle is a Class 2 Cardiovascular device. It is a type of Trocar, used in medical procedures.

The device is supplied with FDA 510(k) clearance, K number K871377, and is regulated under product code DRC. It is manufactured by North American Instrument Corp. and has been cleared through the Traditional 510(k) pathway.

Other devices from North American Instrument Corp.

See all devices from North American Instrument Corp. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Namic Cournand Style Introducer Needle used for?

    The Namic Cournand Style Introducer Needle is used in medical procedures as a type of Trocar, specifically in Cardiovascular applications.

  • Is the Namic Cournand Style Introducer Needle supplied sterile?

    The device data does not specify sterility, it is recommended to consult the manufacturer or packaging for this information.

  • What is the regulatory classification of the Namic Cournand Style Introducer Needle?

    The Namic Cournand Style Introducer Needle is classified as a Class 2 device under product code DRC.