FDA Product Code
FDA Product Code LJS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5970
510(k) Clearances — 302 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100635 | ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 | Arrow Intl., Inc. | 2010-08-27 | Traditional | PDF ↗ |
| K101329 | SYNERGY CT PICC | Health Line International Corporation | 2010-08-19 | Traditional | PDF ↗ |
| K093775 | EVGUIDE TIP LOCATION SYSTEM | Romedex International Srl | 2010-07-15 | Traditional | PDF ↗ |
| K092306 | SECURACATH UNIVERSAL | Interrad Medical, Inc. | 2010-07-09 | Traditional | PDF ↗ |
| K093406 | MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 | AngioDynamics, Inc. | 2010-03-25 | Special | PDF ↗ |
| K093927 | 6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER | C.R. Bard, Inc. | 2010-02-04 | Special | PDF ↗ |
| K093252 | FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER | Footprint Medical, Inc. | 2009-12-17 | Special | PDF ↗ |
| K093366 | NMI PICC II | Navilyst Medical, Inc. | 2009-11-24 | Special | PDF ↗ |
| K093309 | PRO-LINE CT (BASIC TRAY) MODEL MR28036101 | Medcomp ( Medical Components) | 2009-11-24 | Special | PDF ↗ |
| K092040 | PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240 | R4 Vascular, Inc. | 2009-11-18 | Traditional | PDF ↗ |
| K091924 | VPS CATHETER | Vasonova, Inc. | 2009-11-18 | Traditional | PDF ↗ |
| K092347 | PRO-PICC CT | Medcomp | 2009-09-16 | Special | PDF ↗ |
| K091953 | PRO-PICC | Medcomp | 2009-09-16 | Traditional | PDF ↗ |
| K091488 | FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C | Footprint Medical | 2009-09-14 | Traditional | PDF ↗ |
| K091324 | SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET | C.R. Bard, Inc. | 2009-08-07 | Traditional | PDF ↗ |
| K091586 | VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN | Medcomp | 2009-07-23 | Traditional | PDF ↗ |
| K091670 | BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER | Becton, Dickinson & CO | 2009-07-01 | Special | PDF ↗ |
| K091466 | 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 | Medcomp | 2009-06-17 | Special | PDF ↗ |
| K091261 | NMI PICC | Navilyst Medical, Inc. | 2009-05-12 | Special | PDF ↗ |
| K083920 | FLOWPICC CATHETER | Vasonova, Inc. | 2009-05-01 | Traditional | PDF ↗ |
| K083873 | PICC (CT RATED AND NON-RATED) | Pfm Medical, Inc. | 2009-03-19 | Traditional | PDF ↗ |
| K083763 | ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN | R4 Vascular, Inc. | 2009-03-16 | Traditional | PDF ↗ |
| K082481 | FLOWPICC CATHETER | Vasonova, Inc. | 2008-12-17 | Traditional | PDF ↗ |
| K081904 | PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) | Medcomp | 2008-09-23 | Traditional | PDF ↗ |
| K080604 | PRESSURE INJFECTABLE PICC | Arrow International, Inc. | 2008-06-27 | Traditional | PDF ↗ |
| K073451 | PRESSURE INJECTABLE PICC | Arrow International, Inc. | 2008-01-15 | Special | PDF ↗ |
| K072518 | CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS) | Crs Medical Diagnostics, Inc. | 2007-12-20 | Traditional | PDF ↗ |
| K072625 | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) | Cook, Inc. | 2007-12-13 | Traditional | PDF ↗ |
| K072509 | PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY | Medcomp | 2007-11-26 | Traditional | PDF ↗ |
| K072391 | PFM PICC | Pfm Medical, Inc. | 2007-11-19 | Traditional | PDF ↗ |
| K071875 | V-CATH POLY PICC | Hdc Corp. | 2007-11-05 | Traditional | PDF ↗ |
| K072230 | POWERPICC SOLO | C.R. Bard, Inc. | 2007-10-05 | Traditional | PDF ↗ |
| K072196 | ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT | AngioDynamics, Inc. | 2007-08-27 | Special | PDF ↗ |
| K071361 | R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005 | R4 Vascular, Inc. | 2007-08-20 | Traditional | PDF ↗ |
| K070002 | BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER | Boston Scientific | 2007-08-17 | Abbreviated | PDF ↗ |
| K070613 | ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT | AngioDynamics, Inc. | 2007-06-29 | Traditional | PDF ↗ |
| K070996 | 4 FR SINGLE LUMEN (SL) POWERPICC CATHETER | C.R. Bard, Inc. | 2007-05-08 | Special | PDF ↗ |
| K063363 | FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE | Flexicath , Ltd. | 2007-05-07 | Traditional | PDF ↗ |
| K070615 | ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT | AngioDynamics, Inc. | 2007-05-04 | Traditional | PDF ↗ |
| K063848 | POWERGROSHONG PICC CATHETER | C.R. Bard, Inc. | 2007-04-04 | Traditional | PDF ↗ |
| K062579 | OMNIPICC P.I. | Rita Medical Systems, Inc. | 2006-11-28 | Traditional | PDF ↗ |
| K063240 | SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR | C.R. Bard, Inc. | 2006-11-21 | Special | PDF ↗ |
| K062425 | LIFECATH S PICC AND MIDLINE CATHETER | Vygon Corp. | 2006-09-15 | Special | PDF ↗ |
| K052475 | VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS | Vygon Us, LLC | 2006-09-14 | Special | PDF ↗ |
| K061289 | ARROW PRESSURE INJECTABLE PICC | Arrow International, Inc. | 2006-08-24 | Traditional | PDF ↗ |
| K061179 | POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER | C.R. Bard, Inc. | 2006-08-09 | Traditional | PDF ↗ |
| K061936 | KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311 | The Kendall Company | 2006-08-09 | Special | PDF ↗ |
| K061986 | 1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50 | Medcomp | 2006-08-03 | Traditional | PDF ↗ |
| K061240 | SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES | Lucent Medical Systems | 2006-06-02 | Special | PDF ↗ |
| K060887 | ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT | AngioDynamics, Inc. | 2006-04-28 | Special | PDF ↗ |
| K053345 | PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D | Medcomp | 2006-03-17 | Traditional | PDF ↗ |
| K053501 | POWERPICC | Bard Access Systems, Inc. | 2006-01-13 | Special | PDF ↗ |
| K051102 | OMNIPICC PI | Rita Medical Systems, Inc. | 2005-11-23 | Traditional | PDF ↗ |
| K051672 | POWERPICC | Bard Access Systems, Inc. | 2005-11-23 | Traditional | PDF ↗ |
| K051991 | POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE | C.R. Bard, Inc. | 2005-10-20 | Traditional | PDF ↗ |
| K050889 | FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH | Crs Medical Diagnostics, Inc. | 2005-08-26 | Traditional | PDF ↗ |
| K051690 | VYGON NUTRILINE CATHETERS | Vygon Corp. | 2005-08-19 | Traditional | PDF ↗ |
| K050542 | MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER | Marian Medical, Inc. | 2005-07-26 | Traditional | PDF ↗ |
| K051194 | BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669 | Becton, Dickinson & CO | 2005-07-25 | Traditional | PDF ↗ |
| K041849 | TURBO-FLO PICC | Cook, Inc. | 2005-07-21 | Traditional | PDF ↗ |
| K051417 | 6 FR FL POWERHOHN AND POWERLINE CATHETER | C.R. Bard, Inc. | 2005-06-30 | Special | PDF ↗ |
| K050931 | 6 FR DL POWERPICC CATHETER | C.R. Bard, Inc. | 2005-06-15 | Special | PDF ↗ |
| K050185 | POWERHOHN AND POWERLINE CATHETERS | C.R. Bard, Inc. | 2005-05-26 | Traditional | PDF ↗ |
| K043502 | 6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC | C.R. Bard, Inc. | 2005-01-14 | Special | PDF ↗ |
| K030400 | NEOSCI MEDICAL ENDOLUMINAL BRUSH | Neosci Medical, Inc. | 2004-12-22 | Traditional | PDF ↗ |
| K042461 | KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 | Kendall | 2004-12-10 | Abbreviated | PDF ↗ |
| K042491 | BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER | Becton, Dickinson & CO | 2004-11-22 | Traditional | PDF ↗ |
| K041088 | TRIFUSION, MODEL 0609190/0659350 | C.R. Bard, Inc. | 2004-11-01 | Abbreviated | PDF ↗ |
| K041468 | PREMICATH, 1261.205 | Vygon Corp. | 2004-09-09 | Traditional | PDF ↗ |
| K042126 | PICC | Arrow Intl., Inc. | 2004-08-27 | Special | PDF ↗ |
| K041420 | ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT | AngioDynamics, Inc. | 2004-07-26 | Traditional | PDF ↗ |
| K033389 | POWERPICC CATHETERS, MODELS 3175155, 3175135 | C.R. Bard, Inc. | 2004-03-19 | Traditional | PDF ↗ |
| K040446 | ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT | AngioDynamics, Inc. | 2004-03-05 | Special | PDF ↗ |
| K034019 | POLY PER-Q-CATH PICC CATHETERS | C.R. Bard, Inc. | 2004-01-21 | Special | PDF ↗ |
| K034020 | GROSHONG NXT PICC CATHETERS | C.R. Bard, Inc. | 2004-01-21 | Special | PDF ↗ |
| K031718 | LIFEVALVE CENTRAL VENOUS CATHTER | Horizon Medical Products, Inc. | 2003-07-02 | Special | PDF ↗ |
| K031626 | ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT | AngioDynamics, Inc. | 2003-06-19 | Special | PDF ↗ |
| K031129 | POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC | C.R. Bard, Inc. | 2003-05-05 | Special | PDF ↗ |
| K030415 | ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT | AngioDynamics, Inc. | 2003-04-30 | Traditional | PDF ↗ |
| K030270 | 3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON | Medcomp | 2003-04-11 | Traditional | PDF ↗ |
| K030255 | SILICONE DUAL LUMEN RADPICC CATHETERS | C.R. Bard, Inc. | 2003-02-07 | Special | PDF ↗ |
| K023374 | GROSHONG NXT DUAL LUMEN PICC CATHETERS | C.R. Bard, Inc. | 2002-12-18 | Abbreviated | PDF ↗ |
| K021704 | VAXCEL PICC WITH PASV VALVE TECHNOLOGY | Catheter Innovations, Inc. | 2002-06-06 | Special | PDF ↗ |
| K012641 | FAS ENDOLUMINAL BRUSH | Fas Medical , Ltd. | 2001-10-15 | Traditional | PDF ↗ |
| K012902 | POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100; POLY PER-Q-CATH DUAL LUMEN PICC CATHETER, MODEL 3246100 | C.R. Bard, Inc. | 2001-09-10 | Special | PDF ↗ |
| K003839 | CENTRAL VENOUS CATHETER | Boston Scientific Corp | 2001-08-01 | Traditional | PDF ↗ |
| K010349 | DUAL LUMEN MIDLINE CATHETER | Catheter Innovations, Inc. | 2001-02-28 | Special | PDF ↗ |
| K003682 | MEDCOMP Z-CATH | Medical Components, Inc. | 2001-01-26 | Traditional | PDF ↗ |
| K992424 | SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20 | Plastimed Laboratoire Pharmaceutique | 2000-12-29 | Traditional | PDF ↗ |
| K003642 | PLACEMENT-PLUS | Catheter Innovations, Inc. | 2000-12-20 | Special | PDF ↗ |
| K003110 | MEDCOMP BIO-CATH CATHETER LINE | Medcomp | 2000-12-01 | Traditional | PDF ↗ |
| K001874 | PERIPHERALLY INSERTED CENTRAL CATHETER | Utah Medical Products, Inc. | 2000-09-25 | Traditional | PDF ↗ |
| K001901 | POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135 | C.R. Bard, Inc. | 2000-09-19 | Traditional | PDF ↗ |
| K993052 | VYGON 2 FR EPICUTANEO PUR-CATHETER | Vygon Corp. | 2000-08-03 | Traditional | PDF ↗ |
| K993442 | VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR) | Vygon Corp. | 2000-08-03 | Traditional | PDF ↗ |
| K993614 | FAS ENDOLUMINAL BRUSH | Fas Medical , Ltd. | 2000-01-18 | Traditional | PDF ↗ |
| K983544 | VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.) | Vygon Corp. | 1999-01-13 | Traditional | PDF ↗ |
| K983412 | MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T | Medical Components, Inc. | 1998-12-10 | Traditional | PDF ↗ |
| K980090 | ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) | Luther Medical Products, Inc. | 1998-03-24 | Traditional | PDF ↗ |
| K972555 | CATHETER TUNNELER | Gerard Medical, Inc. | 1997-12-22 | Traditional | PDF ↗ |
Product code LJS · Class II · General Hospital. Data: openFDA.