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Torcon NB Advantage Catheters

by Cook Incorporated

510(k) K161822

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK161822 Date27 Oct 2016ClearedStatusActive

Official records

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  • Withdrawn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
DQO
Device class
Class II
Regulation
21 CFR Part 870.1200
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 22 Sep 2026

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

Torcon NB Advantage Catheters are angiographic catheters intended for use in the peripheral and coronary vascular system, including the carotid arteries. They are used in angiographic procedures by physicians trained and experienced in angiographic techniques.

The device is supplied in boxes containing five catheters each, with specific models identified by part numbers such as G05204, G08895, G10756, and G06749. It has received FDA 510(k) clearance under K-number K161822 and is classified under product code DQO with advisory committee review in cardiovascular (CV) devices.

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