Atlas FDA

IV EXTENSION SET SL

FDA 510(k) clearance K791930 · decided 1979-10-26

Clearance details

K-number
K791930
Device name
IV EXTENSION SET SL
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1979-09-27
Decision date
1979-10-26
Days to decision
29 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
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
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
LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Si recall (Z-0914-03)Abbott Laboratories HPD/ADD2003-06-05

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