RENAL LINK
FDA 510(k) clearance K990953 · decided 1999-06-18
Clearance details
- K-number
- K990953
- Device name
- RENAL LINK
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1999-03-22
- Decision date
- 1999-06-18
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KPF
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mcgaw Park, IL, US
- Third-party review
- No
- Expedited review
- No
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| PERITONEAL DIALYSIS CYCLER MODEL PDC1000 (K791676) | J.M. Sounds Electronics Co. | 1979-12-06 |
| CYLER/HEATER FOR PERITONEAL DIALYSIS (K791584) | American Medical Products, Inc. | 1979-11-16 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module recall (Z-0831-06) | Baxter Healthcare Renal Div | 2006-05-03 |
| Baxter Healthcare Corporation, RenalSoft v.1.1 - PD Module; clinical data management softw recall (Z-0832-06) | Baxter Healthcare Renal Div | 2006-05-03 |
| Baxter Healthcare Corporation, Renal Software Suite v.3.1 - HD Module; clinical data manag recall (Z-0833-06) | Baxter Healthcare Renal Div | 2006-05-03 |
| Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw recall (Z-0901-04) | Baxter Healthcare Renal Div | 2004-07-20 |
| Renalsoft software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 recall (Z-0902-04) | Baxter Healthcare Renal Div | 2004-07-20 |
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 |