Atlas FDA

NU-SITE

FDA 510(k) clearance K943897 · decided 1995-02-10

Clearance details

K-number
K943897
Device name
NU-SITE
Applicant
Medex, Inc.
Decision
Substantially Equivalent
Date received
1994-08-10
Decision date
1995-02-10
Days to decision
184 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Hilliard, OH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL recall (Z-0740-2024)Smiths Medical Asd Inc2024-01-17
6IN PRESSURE TUBING, List Number MX20617 recall (Z-0741-2024)Smiths Medical Asd Inc2024-01-17
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R recall (Z-0742-2024)Smiths Medical Asd Inc2024-01-17
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP recall (Z-0743-2024)Smiths Medical Asd Inc2024-01-17
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP recall (Z-0744-2024)Smiths Medical Asd Inc2024-01-17
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R recall (Z-0746-2024)Smiths Medical Asd Inc2024-01-17
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R recall (Z-0747-2024)Smiths Medical Asd Inc2024-01-17