Atlas FDA

RADIATION STERILIZED ADMIN. SET

FDA 510(k) clearance K811078 · decided 1981-07-02

Clearance details

K-number
K811078
Device name
RADIATION STERILIZED ADMIN. SET
Applicant
Travenol Laboratories, S.A.
Decision
Substantially Equivalent
Date received
1981-04-20
Decision date
1981-07-02
Days to decision
73 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Lu recall (Z-1268-2013)Baxter Healthcare Corp.2013-05-07
Baxter Non-DEHP Y-Type Catheter Extension Set, 5.3" (13.5 cm), 1.0 mL, Male Luer Lock Adap recall (Z-0149-2011)Baxter Healthcare Corp.2010-10-27
Baxter Minivolume Extension Set, product code 2C5681; An Rx sterile, nonpyrogenic fluid pa recall (Z-0627-06)Baxter Healthcare Corp.2006-03-24
Baxter Non-DEHP I.V. Catheter Extension Set, product code 2N1194; An Rx sterile, nonpyroge recall (Z-0628-06)Baxter Healthcare Corp.2006-03-24
Baxter Mini-Infuser Microbore Extension Set, product code 2C9203; An Rx sterile, nonpyroge recall (Z-0635-06)Baxter Healthcare Corp.2006-03-24
Baxter Minivolume Extension Set, product code 1C8400; An Rx sterile, nonpyrogenic fluid pa recall (Z-0639-06)Baxter Healthcare Corp.2006-03-24
Baxter Non-DEHP Minivolume Extension Set, product code 1C8690; An Rx sterile, nonpyrogenic recall (Z-0645-06)Baxter Healthcare Corp.2006-03-24
Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension recall (Z-0646-06)Baxter Healthcare Corp.2006-03-24
Baxter Y-Type Minivolume Extension Set, product code 1C8689; An Rx sterile, nonpyrogenic f recall (Z-0649-06)Baxter Healthcare Corp.2006-03-24
Baxter Interlink System Minivolume Extension Set, product code 1C8483; 18'', 1.3 mL Vol., recall (Z-1101-05)Baxter Healthcare Corp.2005-08-06
Baxter Y-Type Minivolume Extension Set; catalog 1C8499; Baxter Healthcare Corporation, Dee recall (Z-0506-03)Baxter Healthcare Corp.2003-02-06
Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8516 and recall (Z-0511-03)Baxter Healthcare Corp.2003-02-06
Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8522 and recall (Z-0512-03)Baxter Healthcare Corp.2003-02-06
Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8527 and recall (Z-0513-03)Baxter Healthcare Corp.2003-02-06
Baxter AutoSyringe Extension Set with 0.22 Micron Filter, catalog 1M8529; Baxter Healthcar recall (Z-0514-03)Baxter Healthcare Corp.2003-02-06
Baxter Minivolume T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filte recall (Z-0515-03)Baxter Healthcare Corp.2003-02-06
Baxter Minivolume Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2 recall (Z-0516-03)Baxter Healthcare Corp.2003-02-06