Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter

Q: What is the product code of K040184?

The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.

FDA 510(k) K040184 · Cobe Cardiovascular, Inc.

Substantially Equivalent

510(k) numberK040184

Submission

Device name: Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter
Applicant: Cobe Cardiovascular, Inc.
Arvada, CO, US
Received: January 26, 2004
Decision date: February 26, 2004
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.4260
Specialty: Cardiovascular
Life-sustaining: Yes

Other 510(k)s with product code DTM

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K242953	KIDS Arterial FiltersDTM · Special	Sorin Group Italia S.R.L.	12/20/2024SE
K242092	MICRO Arterial FiltersDTM · Special	Sorin Group Italia S.R.L.	11/18/2024SE
K231362	OCS Heart Leukocyte Depleting FilterDTM · Traditional	TransMedics, Inc.	10/31/2023SE
K123351	Affinity AF100 Arterial Filter with Carmeda Bioactive SurfaceDTM · Traditional	Medtronic Perfusion Systems	03/19/2013SE
K122760	Affinity AF100 Arterial Filter with Balance BiosurfaceDTM · Traditional	Medtronic, Inc.	12/07/2012SE
K121209	Terumo Pall AL20X Arterial FilterDTM · Special	Terumo Cardiovascular Systems Corporation	05/08/2012SE
K112525	D731 Micro 27 Ph.I.S.I.O. and D733 Micro 40 Ph.I.S.O. Arterial FiltersDTM · Special	Parexel International	09/29/2011SE
K100646	Affinity Pixie Arterial Filter with Balance BiosurfaceDTM · Traditional	Medtronic, Inc.	12/16/2010SE
K093986	Af 620 Ph.I.S.I.O., Af 640 Ph.I.S.I.O. Arterial FiltersDTM · Special	Sorin Group Italia S.R.L.	01/22/2010SE

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K030462	Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700KFM · Special	03/06/2003SE
K021830	Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia SystemDTR · Special	07/02/2002SE
K011835	Cobe RevolutionKFM · Abbreviated	02/12/2002SE
K013480	Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane OxygenatorDTZ · Special	11/16/2001SE
K012763	Sorin Biomedica Smart BCD Vanguard,Surface Modified Blood Cardioplegia SystemDRT · Abbreviated	11/15/2001SE
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Questions and answers

When was Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter cleared by the FDA?

Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter (K040184) received a 510(k) decision of Substantially Equivalent on February 26, 2004, 31 days after the submission was received.

What is the product code of K040184?

The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.