Atlas FDA

I.V. SET WITH DUAL-CHANNEL CASSETTE

FDA 510(k) clearance K865060 · decided 1987-02-06

Clearance details

K-number
K865060
Device name
I.V. SET WITH DUAL-CHANNEL CASSETTE
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1986-12-24
Decision date
1987-02-06
Days to decision
44 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per c recall (Z-1491-2012)Hospira Inc.2012-05-04
LifeShield Latex-Free HEMA Blood PlumSet; Nonvented, 100 inch, with 210 Micron Filter, Pre recall (Z-0133-06)Hospira Inc.2005-11-15
LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filt recall (Z-0134-06)Hospira Inc.2005-11-15
LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filt recall (Z-0135-06)Hospira Inc.2005-11-15
I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion Pumps; recall (Z-0958-03)Abbott Laboratories HPD/ADD2003-06-27
Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Se recall (Z-0936-03)Abbott Laboratories HPD/ADD2003-06-17

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30