Gish Arterial Filter with GBS Coating
FDA 510(k) K023833 · Gish Biomedical, Inc.
510(k) numberK023833
Submission
- Device name
- Gish Arterial Filter with GBS Coating
- Applicant
- Gish Biomedical, Inc.
Houston, TX, US - Received
- November 18, 2002
- Decision date
- March 31, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial…DTM · Special | Medtronic | 01/16/2026SE |
| 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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| K091062 | Medos Hilite Infant Reservoir, Model MVC 0730DTN · Traditional | 08/04/2009SE |
| K083131 | Medos Hilite Reservoir, Model: 4030DTN · Traditional | 07/30/2009SE |
| K082403 | Medos Hilite Oxygenator, Model 7000 & 7000 LTDTZ · Traditional | 05/15/2009SE |
| K082082 | Gish SVR Soft Venous Reservoirs with Ha CoatingDTN · Traditional | 02/04/2009SE |
| K081947 | Gish CAPVRF44 Hardshell Venous Reservoir with Ha CoatingDTN · Traditional | 02/04/2009SE |
| K080708 | Vision Hollow Fiber Oxygenator with Ha CoatingDTZ · Traditional | 02/02/2009SE |
| K081838 | Gish Vision Blood Cardioplegia with Ha CoatingDTR · Traditional | 01/26/2009SE |
| K081881 | Gish Tubing and Connectors with Ha CoatingDWF · Traditional | 01/23/2009SE |
Questions and answers
When was Gish Arterial Filter with GBS Coating cleared by the FDA?
Gish Arterial Filter with GBS Coating (K023833) received a 510(k) decision of Substantially Equivalent on March 31, 2003, 133 days after the submission was received.
What is the product code of K023833?
The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.