ASK-300

FDA 510(k) K882977 · Medical Repackers Co.

Substantially Equivalent

510(k) numberK882977

Submission

Device name
ASK-300
Applicant
Medical Repackers Co.
Fort Payne, AL, US
Received
July 15, 1988
Decision date
January 5, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DQR – Cannula, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1300
Specialty
Cardiovascular

Other 510(k)s with product code DQR

510(k)DeviceApplicantDecision
K131446Integra Jarit Heparin Cannulas, Injectors, and NeedlesDQR · Traditional Integra LifeSciences Corporation10/28/2013SE
K07355918 Fr. Rmi Arterial Perfusion Cannula II, 20 Fr. Rmi Arterial Perfusion Cannula IIDQR · Special Edwards Lifesciences Research Medical01/31/2008SE
K051655Angiodynamics, Inc., Micro Access KitsDQR · Traditional AngioDynamics, Inc.09/12/2005SE
K030398Cardiacassist Transseptal Cannula Set, Model 5132-6221DQR · Traditional Cardiacassist, Inc.05/23/2003SE
K960098Rmi Internal Mammary Artery CannulaDQR · Traditional Research Medical, Inc.03/26/1996SE
K902674Datascope Arterial Cannula W/Access PortDQR · Traditional Datascope Corp.01/16/1991SE
K894784Modified Shiley Femoral Venous CannulaDQR · Traditional Shiley, Inc.03/28/1990SE
K894243Rmi Arterial Perfusion CannulaDQR · Traditional Research Medical, Inc.09/19/1989SE
K884628Harborin Central Venous CatheterDQR · Traditional Harbor Medical Devices, Inc.05/15/1989SE
K884478Daig Collapsible Sterile SleeveDQR · Traditional Daig Corp.02/22/1989SE

More from Daig Corp.

510(k)DeviceDecision
K890575Accutherm PTS-200DWJ · Traditional 05/05/1989SE
K881313IQK-200BTR · Traditional 05/19/1988SE
K881429Yankauer Suction Instru./Laytex Gloves/Suct. Cath.CAZ · Traditional 04/25/1988SE
K874674AIK-100 Anesthesia Induction Kit/TrayCAZ · Traditional 03/02/1988SE

Questions and answers

When was ASK-300 cleared by the FDA?

ASK-300 (K882977) received a 510(k) decision of Substantially Equivalent on January 5, 1989, 174 days after the submission was received.

What is the product code of K882977?

The FDA product code is DQR – Cannula, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1300.