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
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033 Terminated |
LJS | K163452 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032 Terminated |
LJS | K163452 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019 Terminated |
LJS | K163452 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003 Terminated |
LJS | K152409 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) CAN 5F DUAL XCELA PICC, Catalog Number 60M701532 Terminated |
LJS | K152409 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531 Terminated |
LJS | K152409 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936 Terminated |
LJS | K163452 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097 Terminated |
LJS | K121990 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M183481 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL XPP KIT, Catalog Number 60M183104 Terminated |
LJS | K121990 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582 Terminated |
LJS | K152409 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M181578 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) 5F DL BIOFLO PICC, Catalog Number 60M180592 Terminated |
LJS | K142616 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M161567 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M150373 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) 5F DL BIOFLO PASV, Catalog Number 60M141006 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M132324 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PICC, Catalog Number 60M071831 Terminated |
LJS | K142616 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL XPP, Catalog Number 60M030393 Terminated |
LJS | K121990 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS TANDEM 5F DL XPP, Catalog Number 60M019881 Terminated |
LJS | K121990 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895 Terminated |
LJS | K142616 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887 Terminated |
LJS | K142616 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886 Terminated |
LJS | K142616 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872 Terminated |
LJS | K142616 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871 Terminated |
LJS | K142616 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818 Terminated |
LJS | K142616 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124 Terminated |
LJS | K152409 |
| Apr 11, 2018 | Arrow International Inc VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP Terminated |
LJS | K160925 |
| Apr 11, 2018 | Arrow International Inc VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO Terminated |
LJS | K160925 |
| Apr 11, 2018 | Arrow International Inc VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ Terminated |
LJS | K160925 |
| Apr 11, 2018 | Arrow International Inc Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, P Terminated |
LJS | K130876 |
| Apr 11, 2018 | Arrow International Inc ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM Terminated |
LJS | K080604 |
| Apr 11, 2018 | Arrow International Inc ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM Terminated |
LJS | K113277 |
| Apr 11, 2018 | Arrow International Inc Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052 Terminated |
LJS | K930129 |
| Apr 11, 2018 | Arrow International Inc PICC Catheter Trimmer ; Product Code:PC-00001-T Terminated |
LJS | K061289 |
| Feb 6, 2018 | Bard Access Systems Inc. PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration. Terminated |
LJS | K162443 |
| Dec 22, 2017 | Arrow International Inc Arrow Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB Terminated |
LJS | K061289 |
| Nov 27, 2017 | Arrow International Inc Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC
Kit with Chlorag+ard(R) Technology
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) centra Terminated |
LJS | K112896 |
| Oct 17, 2017 | Arrow International Inc ARROW PICC
powered by ARROW VPS
Stylet Terminated |
LJS | K121941 |
| Jul 25, 2017 | Arrow International Inc ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A. Terminated |
LJS | K113277 |
| Jul 25, 2017 | Arrow International Inc ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter Terminated |
LJS | K121941 |
| Jul 24, 2017 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. CVC Tray Pediatrics. Product Code: AMS-9335CP-2. Terminated |
LJS | K954302 |
| Jun 27, 2017 | Arrow International Inc Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology Terminated |
LJS | K112896 |
| Jun 1, 2017 | Arrow International Inc ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC)
The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for i Terminated |
LJS | K113277 |
| Jun 1, 2017 | Arrow International Inc ARROW PICC powered by ARROW VPS Stylet
The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion Terminated |
LJS | K121941 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.