Atlas FDA

GUARDIAN, VOLUMETRIC CONTROL DELIVERY

FDA 510(k) clearance K811933 · decided 1981-07-20

Clearance details

K-number
K811933
Device name
GUARDIAN, VOLUMETRIC CONTROL DELIVERY
Applicant
Avi, Inc.
Decision
Substantially Equivalent
Date received
1981-07-06
Decision date
1981-07-20
Days to decision
14 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large V recall (Z-0658-06)Smiths Medical MD, Inc.2006-03-18
Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large V recall (Z-0659-06)Smiths Medical MD, Inc.2006-03-18
Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large V recall (Z-0660-06)Smiths Medical MD, Inc.2006-03-18
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0464-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0465-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0466-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0467-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0468-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0469-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0470-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0471-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0472-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0473-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0474-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0475-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0476-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0477-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0478-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0479-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0480-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0481-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0482-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0483-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0484-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0485-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0486-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0487-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0488-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0489-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0490-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0491-05)Smiths Medical MD, Inc.2005-02-02
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and recall (Z-0492-05)Smiths Medical MD, Inc.2005-02-02