FDA 510(k) Applications for Medical Device Product Code "FPK"
(Tubing, Fluid Delivery)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K063114 |
COEUR, INC. |
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES |
02/09/2007 |
K041178 |
E-Z-EM, INC. |
EMPOWER TRANSFER SET, (CAT. NO. 7725) |
07/16/2004 |
K063239 |
HOSPIRA, INC. |
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 |
12/11/2006 |
K031808 |
MEDRAD, INC. |
MEDRAD SWABBABLE VALVE TRANSFER SET |
07/11/2003 |
K022431 |
MEDRAD, INC. |
MEDRAD TRANSFER SET |
09/05/2002 |
K131517 |
MEDRAD, INC. / BAYER MEDICAL CARE, INC. |
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING |
08/02/2013 |
K052431 |
MEDTRONIC MINIMED |
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 |
11/29/2005 |
K965208 |
MEDTRONIC MINIMED |
POLYFIN EXTENSION SET, MODELS 126 AND 128 |
02/26/1997 |
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