Panels › General Hospital › Product code LJS · Class 2
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation 880.5970
4510(k)s in 12 months (303 all time)
9recalls in 12 months (332 all time)
305recalls that name a 510(k)
Top companies in LJS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2015 | K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC Navilyst Medical, Inc. | LJS |
| Apr 24, 2015 | K143238 | C3 Wave Medcomp ( Medical Components) | LJS |
| Mar 31, 2015 | K150527 | Xcela Power Injectable PICC Navilyst Medical, Inc. | LJS |
| Mar 19, 2015 | K150448 | NMI PICC III and NMI PICC IV Navilyst Medical, Inc. | LJS |
| Jan 27, 2015 | K142889 | Celerity PICC Tip Confirmation System AngioDynamics, Inc. | LJS |
| Jan 27, 2015 | K141634 | NAUTILUS DELTA Romedex International Srl | LJS |
| Oct 17, 2014 | K142267 | Sherlock 3CG Tip Positioning System Stylet C.R. Bard, Inc. | LJS |
| Oct 14, 2014 | K142616 | PICC Maximal Barrier Nursing Kit Navilyst Medical, Inc. | LJS |
| Sep 29, 2014 | K141633 | PRO-PICC WITH VALVE TECHNOLOGY Medical Components, Inc. | LJS |
| Aug 5, 2014 | K141818 | TURBO-JECT PICC SETS Cook Corporated | LJS |
| Jul 8, 2014 | K141151 | CT MIDLINE Medcomp (Medical Components, Inc.) | LJS |
| Jun 13, 2014 | K140799 | CELERITY SYSYEM Medcomp (Medical Components, Inc.) | LJS |
| Mar 14, 2014 | K140345 | THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) C.R. Bard, Inc. | LJS |
| Mar 5, 2014 | K140266 | NMI PICC IV Navilyst Medical, Inc. | LJS |
| Dec 23, 2013 | K133634 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET Cook, Inc. | LJS |
| Nov 20, 2013 | K133264 | NMI PICC III Navilyst Medical, Inc. | LJS |
| Nov 5, 2013 | K132567 | ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN Covidien | LJS |
| Oct 22, 2013 | K130897 | MEDCOMP VASCU-PICC WITH VALVE Medcomp ( Medical Components) | LJS |
| Oct 11, 2013 | K132885 | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET Cook Incorporated | LJS |
| Aug 16, 2013 | K132334 | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET Cook, Inc. | LJS |
| Aug 16, 2013 | K131687 | 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET Medical Components, Inc. | LJS |
| Jul 31, 2013 | K131942 | NMI PICC III CATHETER, NMI HPICC III CATHETER Navilyst Medical, Inc. | LJS |
| Jun 3, 2013 | K130507 | FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER Footprint Medical, Inc. | LJS |
| May 15, 2013 | K123617 | 3F PRO-PICC Medical Components, Inc. | LJS |
| May 9, 2013 | K131038 | NMI PICC MAXIMAL BARRIER NURSING KITS Navilyst Medical, Inc. | LJS |
| Apr 26, 2013 | K130876 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET Arrow International, Inc. | LJS |
| Mar 8, 2013 | K130034 | UNI-PICC Health Line International Corporation | LJS |
| Jan 3, 2013 | K123759 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET Arrow International, Inc. (Subsidiary of Teleflex | LJS |
| Dec 12, 2012 | K122423 | VASU-PICC Medical Components, Inc. | LJS |
| Nov 29, 2012 | K121501 | ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) Arrow International (Subsidiary of Teleflex Inc.) | LJS |
| Nov 6, 2012 | K113225 | NYLUS PICC Semprus Biosciences | LJS |
| Oct 18, 2012 | K122882 | NMI HPICC III Navilyst Medical, Inc. | LJS |
| Sep 20, 2012 | K122545 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.) | LJS |
| Sep 7, 2012 | K121941 | ARROW PICC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.) | LJS |
| Aug 23, 2012 | K121089 | NMI PICC III Navilyst Medical, Inc. | LJS |
| Aug 3, 2012 | K121990 | PICC CONVENIENCE KIT Navilyst Medical, Inc. | LJS |
| Jun 21, 2012 | K113277 | ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS Arrow International, Inc. | LJS |
| Jun 6, 2012 | K121094 | MEDCOMP VASCU-PICC & MIDLINE CATHETERS Medical Components, Inc. | LJS |
| May 10, 2012 | K112896 | ARRW EVOLUTION Arrow International (Subsidiary of Teleflex Inc.) | LJS |
| May 2, 2012 | K120981 | 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC Medical Components, Inc. | LJS |
| May 2, 2012 | K120980 | 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC Medical Components, Inc. | LJS |
| Mar 19, 2012 | K113808 | THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) C.R. Bard, Inc. | LJS |
| Dec 20, 2011 | K113043 | DIRECT ANTIBIOTIC INFUSION KIT Summit Medical Products, Inc. | LJS |
| Oct 20, 2011 | K112744 | SAPIENS TIP CONFIRMATION SYSTEM C.R. Bard, Inc. | LJS |
| Sep 21, 2011 | K110914 | TRIPLE LUMEN PFM PICC Pfm Medical, Inc. | LJS |
| Aug 12, 2011 | K110627 | NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER Marvao Medical Devices, Ltd. | LJS |
| Jul 29, 2011 | K111906 | XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY Navilyst Medical, Inc. | LJS |
| Jun 14, 2011 | K111244 | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) Cook, Inc. | LJS |
| Dec 21, 2010 | K102966 | 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC Medcomp | LJS |
| Nov 17, 2010 | K102159 | POWERPICC SV CATHETERS C.R. Bard, Inc. | LJS |
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