Product code FPB
- Device name
- Filter, Infusion Line
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5440
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233277 | Filter Needle for Single Use | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-05-10 |
| K143583 | Cathivex ¿GV filter units | Merck Millipore , Ltd. | 2015-08-11 |
| K113227 | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | Baxter Healthcare Corp | 2011-12-08 |
| K021293 | ARTERIA BLOOD FILTER | Arteria Medical Science, Inc. | 2002-08-22 |
| K993379 | PALL SUPOR AEF FILTER | Pall Corp. | 1999-12-16 |
| K974661 | 0.2 U BACTERIAL FILTER | Sims Deltec, Inc. | 1998-02-11 |
| K964283 | AUTOPRIME | Arbor Technologies, Inc. | 1997-01-22 |
| K954331 | PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) | Pall Biomedical Products Co. | 1997-01-09 |
| K933523 | I.V. FILTER SET | Mediziv Medical Products 1987 , Ltd. | 1995-05-19 |
| K941628 | 40 MICRON BLOOD TRANSFUSION FILTER | Douglas Medical Products Corp. | 1995-02-16 |
| K942625 | 1.2 MICRON AIR ELIMINATING FILTER | The Medi-Dose Group | 1994-10-07 |
| K943127 | PHARMASSURE LARGE VOLUME TRANSFER FILTERS | Gelman Sciences, Inc. | 1994-09-29 |
| K942532 | 2 MICRON AIR ELIMINATING FILTER | Medi-Dose, Inc. | 1994-08-17 |
| K941684 | IVEX-2 EXTENSION SET WITH Y-INJECTION SITE | Abbott Laboratories | 1994-08-03 |
| K942275 | VIAL VENT FILTER | Gelman Sciences, Inc. | 1994-07-26 |
| K940980 | CHARGED SUPOR(R) FILTER EXTENSION SET | B. Braun of America, Inc. | 1994-07-14 |
| K933869 | EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER | Baxter Healthcare Corp | 1994-04-26 |
| K940293 | 1.2 MICRON FINAL FILTER WITH EXTENSION TUBE | Puritas Health Care, Inc. | 1994-03-28 |
| K933294 | MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES | Aesculap, Inc. | 1994-02-09 |
| K935641 | 0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS | Evans Medical, Inc. | 1994-01-28 |
| K932301 | FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER | Baxter Healthcare Corp | 1993-11-10 |
| K931441 | FENWAL 40 MICRON TRANSFUSION FILTER | Baxter Healthcare Corp | 1993-09-21 |
| K920736 | IVEX-HP96 EXTENDED LIFE FILTER SET | Abbott Laboratories | 1993-04-23 |
| K913308 | IVEX-TPN EXTENSION FILTER SET | Abbott Laboratories | 1992-01-15 |
| K912848 | I.V. FILTER EXTENSION SET | Filtertek, Inc. | 1991-11-29 |
| K905794 | PALL 3N1 FILTER | Pall Biomedical Products Co. | 1991-06-13 |
| K911451 | I.V. EXTENDER SET | Filtertek, Inc. | 1991-06-06 |
| K896333 | CMS IV FILTERS | Churchill Medical Systems, Inc. | 1990-01-11 |
| K896292 | 1.2 MICRON FILTER WITH IV SET | Kendall Mcgaw Laboratories, Inc. | 1989-12-08 |
| K894954 | .22 & 1.2 MICRON IV FILTERS | Churchill Medical Systems, Inc. | 1989-11-13 |
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| 08498840010310 | VYGON | Vygon Corporation | 2017-07-28 |
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| 08426314575690 | GRI-BAG | LABORATORIOS GRIFOLS SA | 2017-04-05 |
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| 10351688500441 | Medex | ICU MEDICAL, INC. | 2017-01-03 |
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| H67140200050 | HEMO-NATE | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
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| H67140200090 | HEMO-NATE | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67140205090 | HEMO-TAP | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67140206090 | HEMO-TAP | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| 08498840005262 | VYGON | Vygon Corporation | 2016-08-09 |
| 08498840005255 | VYGON | Vygon Corporation | 2016-08-09 |
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| 08498840001042 | VYGON | Vygon Corporation | 2016-08-04 |
| 08498840000922 | VYGON | Vygon Corporation | 2016-08-03 |