Atlas FDA

CVP POLYURETHANE CATHETER

FDA 510(k) clearance K961552 · decided 1997-02-10

Clearance details

K-number
K961552
Device name
CVP POLYURETHANE CATHETER
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1996-04-22
Decision date
1997-02-10
Days to decision
294 days
Clearance type
Traditional
Product code
FOZ
Device class
2
Regulation number
880.5200
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
18 Gauge thin wall needle as part of a Central Venous Catheter Kit recall (Z-0543-04)Abbott Laboratories HPD/ADD/GPRD2004-02-24

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