Gas Filter

FDA 510(k) K993060 · Olson Medical Sales, Inc.

Substantially Equivalent

510(k) numberK993060

Submission

Device name
Gas Filter
Applicant
Olson Medical Sales, Inc.
Somerset, NJ, US
Received
September 13, 1999
Decision date
March 28, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOD – Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4270
Specialty
Cardiovascular

Other 510(k)s with product code JOD

510(k)DeviceApplicantDecision
K890504Cardiotomy/Autotransfusion/Pleural Drainage VenousJOD · Traditional Gish Biomedical, Inc.03/10/1989SE
K875095Pall Cardioplegia Plus Filter W/Posidyne MembraneJOD · Traditional Pall Biomedical Products Co.02/29/1988SE
K874405Pall Stat Prime(Tm) Blood Filter for Extra. UseJOD · Traditional Pall Biomedical Products Co.12/30/1987SE
K855067Swank Cardiotomy Suction Line Blood Filter CA100JOD · Traditional Cobe Laboratories, Inc.02/26/1986SE
K841958Cardio Metrics Cardiotomy ReservoirJOD · Traditional Sterile Design, Inc.10/15/1984SE
K830634Cardiotomy FilterJOD · Traditional Texas Medical Products, Inc.06/30/1983SE
K823260Interface Cardiotomy Blood Filter #51JOD · Traditional Medical, Inc.11/24/1982SE
K823259Interface Cardiotomy Blood Filter #50JOD · Traditional Medical, Inc.11/24/1982SE
K812243Interface Cardiotomy Blood Filter #51JOD · Traditional Medical, Inc.08/25/1981SE
K781383Interface Cardiotomy Blood FilterJOD · Traditional Medical, Inc.09/27/1978SE

More from Medical, Inc.

510(k)DeviceDecision
K000977Components for Cardiovascular Procedure Kit - Heat Exchanger CoilsDTR · Traditional 03/23/2001SE
K993062Chest Drainage TubingDWE · Traditional 12/10/1999SE
K992906Components for Cardiovascular Procedure KitDTL · Traditional 11/10/1999SE

Questions and answers

When was Gas Filter cleared by the FDA?

Gas Filter (K993060) received a 510(k) decision of Substantially Equivalent on March 28, 2000, 197 days after the submission was received.

What is the product code of K993060?

The FDA product code is JOD – Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4270.