CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)
FDA 510(k) clearance K970662 · decided 1998-03-11
Clearance details
- K-number
- K970662
- Device name
- CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1997-02-21
- Decision date
- 1998-03-11
- Days to decision
- 383 days
- Clearance type
- Traditional
- Product code
- MSF
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mcgaw Park, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corp
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR (K023615) | Gambro Renal Products | 2003-05-06 |
| GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER (K994390) | Gambro Healthcare | 2000-10-26 |
| ALTRA NOVA 200 HEMODIALYZER (K970681) | Althin Medical AB an Affiliate of Baxter Intl | 1998-07-23 |
| ALTRA FLUX 200 HEMODIALYZER (K970679) | Althin Medical AB an Affiliate of Baxter Intl | 1998-07-23 |
| CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (K970653) | Baxter Healthcare Corp | 1998-03-11 |
| CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) (K970663) | Baxter Healthcare Corp | 1998-01-11 |
| PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) (K970648) | Renal Systems, Inc. | 1998-01-05 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |