Atlas FDA

DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST

FDA 510(k) clearance K910215 · decided 1991-04-09

Clearance details

K-number
K910215
Device name
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST
Applicant
Cd Medical, Inc.
Decision
Substantially Equivalent
Date received
1991-01-17
Decision date
1991-04-09
Days to decision
82 days
Clearance type
Traditional
Product code
FKP
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Miami Lakes, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part use recall (Z-1253-06)Baxter Healthcare Renal Div2006-07-25
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA an recall (Z-0766-06)Baxter Healthcare Renal Div2006-04-18
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA an recall (Z-0347-06)Baxter Healthcare Renal Div2006-01-06
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series recall (Z-0395-05)Baxter Healthcare Renal Div2004-12-02
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series recall (Z-0833-03)Baxter Healthcare Corp.2003-05-15