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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