DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
FDA 510(k) clearance K970446 · decided 1997-06-02
Clearance details
- K-number
- K970446
- Device name
- DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
- Applicant
- Althin Medical AB an Affiliate of Baxter Intl
- Decision
- Substantially Equivalent
- Date received
- 1997-02-05
- Decision date
- 1997-06-02
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Cor recall (Z-0173-2012) | Baxter Healthcare Renal Div | 2011-11-07 |
| Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part use recall (Z-1253-06) | Baxter Healthcare Renal Div | 2006-07-25 |
| Baxter System 1000 Single Patient Hemodialysis Systems, product codes SYS1000L3, SYS1000L3 recall (Z-1394-05) | Baxter Healthcare Renal Div | 2005-08-24 |
| System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM recall (Z-0367-05) | Baxter Healthcare Renal Div | 2004-12-24 |
| Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series recall (Z-0583-04) | Baxter Healthcare Renal Div | 2004-07-20 |