FDA Product Code
FDA Product Code FPK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5440
510(k) Clearances — 64 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K131517 | MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING | Medrad, Inc. / Bayer Medical Care, Inc. | 2013-08-02 | Special | PDF ↗ |
| K063114 | DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES | Coeur, Inc. | 2007-02-09 | Abbreviated | PDF ↗ |
| K063239 | LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 | Hospira, Inc. | 2006-12-11 | Traditional | PDF ↗ |
| K052431 | MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 | Medtronic Minimed | 2005-11-29 | Traditional | PDF ↗ |
| K041178 | EMPOWER TRANSFER SET, (CAT. NO. 7725) | E-Z-Em, Inc. | 2004-07-16 | Traditional | PDF ↗ |
| K031808 | MEDRAD SWABBABLE VALVE TRANSFER SET | Medrad, Inc. | 2003-07-11 | Special | PDF ↗ |
| K022431 | MEDRAD TRANSFER SET | Medrad, Inc. | 2002-09-05 | Traditional | PDF ↗ |
| K965208 | POLYFIN EXTENSION SET, MODELS 126 AND 128 | Medtronic Minimed | 1997-02-26 | Traditional | PDF ↗ |
| K953864 | SILCLEAR TUBING (MODIFICATION) | Degania Silicone , Ltd. | 1995-11-06 | Traditional | PDF ↗ |
| K950508 | SYSMEX SF-3000 | Sysmex Corp. | 1995-11-03 | Traditional | PDF ↗ |
| K952243 | EXTENSION SET/I.V. SET | Coast Medical, Inc. | 1995-07-26 | Traditional | PDF ↗ |
| K952663 | 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP | Distronic Sterile Products, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K950861 | RECONSTITUTION ACCESSOREIS | Organon, Inc. | 1995-05-26 | Traditional | PDF ↗ |
| K933524 | EXTENTION SET | Mediziv Medical Products 1987 , Ltd. | 1995-05-23 | Traditional | PDF ↗ |
| K950200 | IVID | Scott/Ross Designs, Inc. | 1995-03-24 | Traditional | PDF ↗ |
| K943992 | SILCLEAR TUBING | Degania Silicone , Ltd. | 1995-03-16 | Traditional | PDF ↗ |
| K943206 | VARIOUS TUBING | Prn Services, Inc. | 1995-03-09 | Traditional | PDF ↗ |
| K945184 | INTRAVASCULAR ADMINISTRATION SET | Distronic Sterile Products, Inc. | 1995-02-08 | Traditional | PDF ↗ |
| K941214 | LIFESHIELD EXTENSION SET | Abbott Mfg., Inc. | 1994-10-03 | Traditional | PDF ↗ |
| K935642 | EVANS MEDICAL EXTENSION SETS | Evans Medical, Inc. | 1994-01-28 | Traditional | PDF ↗ |
| K921450 | NON-INVASIVE TUBING | Specialty Medical Sales, Inc. | 1993-02-05 | Traditional | PDF ↗ |
| K923972 | OPHTHALMIC FLUID DISTRIBUTION SETS | Visitec Co. | 1992-11-04 | Traditional | PDF ↗ |
| K915560 | LO-PROFILE EXTENSION SET | Douglas Medical Products Corp. | 1992-05-14 | Traditional | PDF ↗ |
| K912103 | LIFESHIELD EXTENSION SET | Abbott Laboratories | 1991-12-13 | Traditional | PDF ↗ |
| K910906 | CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS | Tri-State Hospital Supply Corp. | 1991-04-01 | Traditional | PDF ↗ |
| K891009 | INTRAVASCULAR ADMINISTRATION SET MODEL 60040 | 3M Company | 1989-05-16 | Traditional | PDF ↗ |
| K891005 | INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050 | 3M Company | 1989-05-11 | Traditional | PDF ↗ |
| K883718 | MERIT HI-FLEX(TM) | Merit Medical Systems, Inc. | 1989-01-30 | Traditional | PDF ↗ |
| K884156 | HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET | Sechrist Industries, Inc. | 1988-11-14 | Traditional | PDF ↗ |
| K884370 | CMS IV EXTENSION SETS | Churchill Medical Systems, Inc. | 1988-11-07 | Traditional | PDF ↗ |
| K875186 | IV EXTENSION SET | Marquette Medical, Inc. | 1988-02-16 | Traditional | PDF ↗ |
| K873465 | VAN DELLEN BACTERIA FILTER | Van Dellen, Ltd. | 1988-01-20 | Traditional | PDF ↗ |
| K873852 | INFUSION MANIFOLD | Advanced Surgical Products, Inc. | 1987-11-23 | Traditional | PDF ↗ |
| K874360 | PLASTIC TUBING CONNECTOR | American Medical Technology, Inc. | 1987-11-17 | Traditional | PDF ↗ |
| K871085 | EXTENSION TUBE PUMP SET | Churchill Corp. | 1987-06-15 | Traditional | PDF ↗ |
| K871540 | SWIVEL CONNECTORS #014452/#014453/#014459-120 | Clinical Connections, Inc. | 1987-04-30 | Traditional | PDF ↗ |
| K870416 | LP EXTENSION SETS | North Coast Medi-Tek | 1987-04-06 | Traditional | PDF ↗ |
| K870912 | T-CONNECTORS 014500/014501/014502/014503-120 | Clinical Connections, Inc. | 1987-03-17 | Traditional | PDF ↗ |
| K870326 | VARIOUS LUER AND TUBING FITTINGS | Clinical Connections, Inc. | 1987-02-10 | Traditional | PDF ↗ |
| K864692 | EXTENSION SETS | Salt Creek Medical Technologies | 1986-12-18 | Traditional | PDF ↗ |
| K864395 | LOW VOLUME EXTENSION SET | Panamedix, Inc. | 1986-12-16 | Traditional | PDF ↗ |
| K861626 | CHURCHILL EXTENSION TUBE | Churchill Corp. | 1986-06-02 | Traditional | PDF ↗ |
| K854629 | CHURCHILL-H EXTENSION TUBE | Churchill Corp. | 1985-12-10 | Traditional | PDF ↗ |
| K834164 | SPINAL NEEDLES & ACCESSORY | Elfa Trading Co. | 1983-12-13 | Traditional | PDF ↗ |
| K833659 | IV EXTENSION SET | Dna Medical, Inc. | 1983-11-29 | Traditional | PDF ↗ |
| K833076 | C-FLEX MEDICAL GRADE TUBING | Concept, Inc. | 1983-11-21 | Traditional | PDF ↗ |
| K832758 | RED COLOR-TINTED TUBING | Custom Medical, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K820527 | ANESTHESIA EXTENSION TUBES | David Simmonds Co., Inc. | 1982-03-18 | Traditional | PDF ↗ |
| K812981 | FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) | Venusa , Ltd. | 1981-11-06 | Traditional | PDF ↗ |
| K811847 | SEA MEDICAL PRODUCTS LO-VOL | Sea Medical Products, Inc. | 1981-07-13 | Traditional | PDF ↗ |
| K810005 | SAFEED EXTENSION TUBES | Terumo Medical Corp. | 1981-02-05 | Traditional | PDF ↗ |
| K800879 | CLEAR PLASTIC CONNECTING TUBES | Harvard Laboratories | 1980-06-17 | Traditional | PDF ↗ |
| K800877 | ANESTHESIA EXTENSION TUBES | Harvard Laboratories | 1980-06-17 | Traditional | PDF ↗ |
| K800825 | EXTENSION SET QUEST CODE #3000 | Quest Medical, Inc. | 1980-05-14 | Traditional | PDF ↗ |
| K781087 | MEDICAL GRADE SILICONE ELASTOMER TUBING | Mcghan Medical Corp. | 1978-11-22 | Traditional | PDF ↗ |
| K780673 | CENTRAL CATHETER KIT | Argon Medical Corp. | 1978-05-16 | Traditional | PDF ↗ |
| K780396 | NASAL GASTRIC TUBE RETAINER | Mor-Mac, Inc. | 1978-03-22 | Traditional | PDF ↗ |
| K772119 | TIME WATCH | Akzona, Inc. | 1977-11-14 | Traditional | PDF ↗ |
| K771269 | BLOOD COLLECTION SET TYPE H | Berman, Pcp & Consultants, Inc. | 1977-09-12 | Traditional | PDF ↗ |
| K771387 | MONITORING LINES & FLUID ADMIN. | Norton Performance Plastics Corp. | 1977-08-22 | Traditional | PDF ↗ |
| K770945 | POUCH, TYVEK-POLYMYLON | Medical Disposables Intl., Inc. | 1977-06-29 | Traditional | PDF ↗ |
| K770596 | CONNECTORS | Abco Dealers, Inc. | 1977-06-20 | Traditional | PDF ↗ |
| K770174 | LUER-LOCK EXTENSION SET | American Viggo | 1977-03-30 | Traditional | PDF ↗ |
| K770108 | TUBE HOLDING DEVICE | Pharmaseal Div., Baxter Healthcare Corp. | 1977-03-10 | Traditional | PDF ↗ |
Product code FPK · Class II · General Hospital. Data: openFDA.