Atlas FDA

CADD-1 5100 AMBULATORY INFUSION PUMP

FDA 510(k) clearance K843772 · decided 1984-12-06

Clearance details

K-number
K843772
Device name
CADD-1 5100 AMBULATORY INFUSION PUMP
Applicant
Deltec Systems, Inc.
Decision
Substantially Equivalent
Date received
1984-09-25
Decision date
1984-12-06
Days to decision
72 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
St. Paul, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx onl recall (Z-1286-2015)Smiths Medical ASD, Inc.2015-03-17
CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper in recall (Z-0987-2009)Smiths Medical MD, Inc.2009-04-20
Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 50 ml, Reorder No. recall (Z-0876-2008)Smiths Medical MD, Inc.2008-02-13
Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml., Reorder No recall (Z-0877-2008)Smiths Medical MD, Inc.2008-02-13
Smiths CADD Yellow Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml, Reor recall (Z-0878-2008)Smiths Medical MD, Inc.2008-02-13
Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented st recall (Z-1213-2007)Smiths Medical MD, Inc.2007-08-30
Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper i recall (Z-1214-2007)Smiths Medical MD, Inc.2007-08-30
Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper i recall (Z-1215-2007)Smiths Medical MD, Inc.2007-08-30