Chest Drainage Tubing

FDA 510(k) K993062 · Olson Medical Sales, Inc.

Substantially Equivalent

510(k) numberK993062

Submission

Device name
Chest Drainage Tubing
Applicant
Olson Medical Sales, Inc.
Somerset, NJ, US
Received
September 13, 1999
Decision date
December 10, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DWE – Tubing, Pump, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4390
Specialty
Cardiovascular

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K142607AngioVac CircuitDWE · Traditional Angiodynamics12/11/2014SE
K092486Vortex Medical Angiovac Cardiopulmonary Bypass CircuitDWE · Traditional Vortex Medical, Inc.08/28/2009SE
K080592HLM Tubing Set with Bioline CoatingDWE · Special Maquet Cardiopulmonary, AG09/11/2008SE
K053025Jostra HLM Tubing SetDWE · Traditional Maquet Cardiopulmonary, AG11/10/2005SE
K022857Pump Tubing with X-CoatingDWE · Special Terumo Cardiovascular Systems Corporation09/19/2002SE
K013578Pump TubingDWE · Traditional Terumo Cardiovascular Systems Corp.01/22/2002SE
K993189Cardiopulmonary Bypass Pump Tubing - 1/4 Inch Tubing, Cardiopulmonary Bypass Pump Tubing…DWE · Traditional Terumo Corp.03/01/2000SE
K981613Cobe Smarxt Tubing and ConnectorsDWE · Traditional Cobe Cardiovascular, Inc.10/26/1998SE

More from Cobe Cardiovascular, Inc.

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K000977Components for Cardiovascular Procedure Kit - Heat Exchanger CoilsDTR · Traditional 03/23/2001SE
K993060Gas FilterJOD · Traditional 03/28/2000SE
K992906Components for Cardiovascular Procedure KitDTL · Traditional 11/10/1999SE

Questions and answers

When was Chest Drainage Tubing cleared by the FDA?

Chest Drainage Tubing (K993062) received a 510(k) decision of Substantially Equivalent on December 10, 1999, 88 days after the submission was received.

What is the product code of K993062?

The FDA product code is DWE – Tubing, Pump, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4390.