Atlas FDA

ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE

FDA 510(k) clearance K100704 · decided 2010-05-14

Clearance details

K-number
K100704
Device name
ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
Applicant
Disetronic Medical Systems AG
Decision
Substantially Equivalent
Date received
2010-03-12
Decision date
2010-05-14
Days to decision
63 days
Clearance type
Special
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511046001. AC FLEXLINK P recall (Z-1480-2011)Roche Insulin Delivery Systems Inc.2011-03-10
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511054001. AC FLEXLINK P recall (Z-1481-2011)Roche Insulin Delivery Systems Inc.2011-03-10
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK P recall (Z-1482-2011)Roche Insulin Delivery Systems Inc.2011-03-10
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510970001. AC FLEXLINK P recall (Z-1483-2011)Roche Insulin Delivery Systems Inc.2011-03-10
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510988001. AC FLEXLINK P recall (Z-1484-2011)Roche Insulin Delivery Systems Inc.2011-03-10
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510961001. AC FLEXLINK P recall (Z-1485-2011)Roche Insulin Delivery Systems Inc.2011-03-10
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511003001. AC FLEXLINK P recall (Z-1486-2011)Roche Insulin Delivery Systems Inc.2011-03-10
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511020001. AC FLEXLINK P recall (Z-1487-2011)Roche Insulin Delivery Systems Inc.2011-03-10
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510996001. AC FLEXLINK P recall (Z-1488-2011)Roche Insulin Delivery Systems Inc.2011-03-10
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510945001. AC FLEXLINK P recall (Z-1489-2011)Roche Insulin Delivery Systems Inc.2011-03-10
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510953001. AC FLEXLINK P recall (Z-1490-2011)Roche Insulin Delivery Systems Inc.2011-03-10
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510937001. AC FLEXLINK P recall (Z-1491-2011)Roche Insulin Delivery Systems Inc.2011-03-10
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511089001. An infusion s recall (Z-1492-2011)Roche Insulin Delivery Systems Inc.2011-03-10