CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G)
FDA 510(k) K970663 · Baxter Healthcare Corp
510(k) numberK970663
Submission
- Device name
- CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G)
- Applicant
- Baxter Healthcare Corp
Mcgaw Park, IL, US - Received
- February 21, 1997
- Decision date
- January 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSF – Hemodialyzer, Re-Use, High Flux
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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|---|---|---|---|
| K023615 | Gambro Polyflux 6 LR, 8 LR and 10 LRMSF · Traditional | Gambro Renal Products | 05/06/2003SE |
| K994390 | Gambro Polyflux 17R, Capillary Dialyzer/ FilterMSF · Traditional | Gambro Healthcare | 10/26/2000SE |
| K970681 | Altra Nova 200 HemodialyzerMSF · Traditional | Althin Medical AB an Affiliate of Baxter Intl | 07/23/1998SE |
| K970679 | Altra Flux 200 HemodialyzerMSF · Traditional | Althin Medical AB an Affiliate of Baxter Intl | 07/23/1998SE |
| K970662 | Ca Cellulose Acetate Hollow Fiber Dialyzer (CA-170/CA-210)MSF · Traditional | Baxter Healthcare Corp | 03/11/1998SE |
| K970653 | Cahp High Performance Cellulose Diacetate (Capillary, Hollow Fiber)MSF · Traditional | Baxter Healthcare Corp | 03/11/1998SE |
| K970648 | Primus Hollow Fiber Dialyzer (Models 1000,1000S,1350,1350S,2000,2000S)MSF · Traditional | Renal Systems, Inc. | 01/05/1998SE |
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Questions and answers
When was CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G) cleared by the FDA?
CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G) (K970663) received a 510(k) decision of Substantially Equivalent on January 11, 1998, 324 days after the submission was received.
What is the product code of K970663?
The FDA product code is MSF – Hemodialyzer, Re-Use, High Flux, a Class II (moderate risk) device regulated under 21 CFR 876.5860.