ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
FDA 510(k) clearance K954987 · decided 1996-08-08
Clearance details
- K-number
- K954987
- Device name
- ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
- Applicant
- Althin Medical AB an Affiliate of Baxter Intl
- Decision
- Substantially Equivalent
- Date received
- 1995-10-31
- Decision date
- 1996-08-08
- Days to decision
- 282 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 |
|---|---|---|
| System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA an recall (Z-0179-2010) | Baxter Healthcare Renal Div | 2009-11-12 |