Atlas FDA

ULTRAFLEX INFUSION SET

FDA 510(k) clearance K033892 · decided 2004-03-09

Clearance details

K-number
K033892
Device name
ULTRAFLEX INFUSION SET
Applicant
Disetronic Medical Systems AG
Decision
Substantially Equivalent
Date received
2003-12-16
Decision date
2004-03-09
Days to decision
84 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Burgdorf, SE
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Catalog Number INF 04540786001. recall (Z-1116-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Dis recall (Z-1117-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-1 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540824001. recall (Z-1118-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-1 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540867001. recall (Z-1119-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-1 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540883001 (Di recall (Z-1120-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-1 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540905001. recall (Z-1121-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-2 infusion set; 8 mm 24'' (60 cm); Catalog number INF 04540921001. recall (Z-1122-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-2 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540930001. recall (Z-1123-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-2 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540948001. recall (Z-1124-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-2 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540956001. recall (Z-1125-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-2 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540964001. recall (Z-1126-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-2 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540972001. recall (Z-1127-06)Disetronic Medical Systems, Inc.2006-07-08