FPK — Tubing, Fluid Delivery Class II
FDA product code FPK covers "Tubing, Fluid Delivery", a Class II medical device regulated under 21 CFR 880.5440. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FPK
- Device Class
- Class II
- Regulation Number
- 880.5440
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K131517 | medrad, inc. / bayer medical care | MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING | August 2, 2013 |
| K063114 | coeur | DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES | February 9, 2007 |
| K063239 | hospira | LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, | December 11, 2006 |
| K052431 | medtronic minimed | MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801 | November 29, 2005 |
| K041178 | e-z-em | EMPOWER TRANSFER SET, (CAT. NO. 7725) | July 16, 2004 |
| K031808 | medrad | MEDRAD SWABBABLE VALVE TRANSFER SET | July 11, 2003 |
| K022431 | medrad | MEDRAD TRANSFER SET | September 5, 2002 |
| K965208 | medtronic minimed | POLYFIN EXTENSION SET, MODELS 126 AND 128 | February 26, 1997 |
| K953864 | degania silicone | SILCLEAR TUBING (MODIFICATION) | November 6, 1995 |
| K950508 | sysmex | SYSMEX SF-3000 | November 3, 1995 |
| K952243 | coast medical | EXTENSION SET/I.V. SET | July 26, 1995 |
| K952663 | distronic sterile products | 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON | July 14, 1995 |
| K950861 | organon | RECONSTITUTION ACCESSOREIS | May 26, 1995 |
| K933524 | mediziv medical products 1987 | EXTENTION SET | May 23, 1995 |
| K950200 | scott/ross designs | IVID | March 24, 1995 |
| K943992 | degania silicone | SILCLEAR TUBING | March 16, 1995 |
| K943206 | prn services | VARIOUS TUBING | March 9, 1995 |
| K945184 | distronic sterile products | INTRAVASCULAR ADMINISTRATION SET | February 8, 1995 |
| K941214 | abbott mfg | LIFESHIELD EXTENSION SET | October 3, 1994 |
| K935642 | evans medical | EVANS MEDICAL EXTENSION SETS | January 28, 1994 |