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) |
|---|---|---|---|
| Dec 20, 2019 | Arrow International Inc Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm
EU-05052-HPMSB Terminated |
LJS | K061289 |
| Dec 20, 2019 | Arrow International Inc PICC Set- PR-35052-HPHNM Terminated |
LJS | K113277 |
| Apr 23, 2019 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
Product Code:PR 45552 HPHNM Terminated |
LJS | K112896 |
| Apr 23, 2019 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
Product Code: PR 45552 HPHNL Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
Product Code:PR 45541 HPHNM Terminated |
LJS | K112896 |
| Apr 23, 2019 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
Product Code: PR 45541 HPHNL Terminated |
LJS | K112896 |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance JACC
Product Code: JRT 43552 HPHNM Terminated |
LJS | K132133 |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance JACC
Product Code: JRT 43541 HPHNM Terminated |
LJS | K132133 |
| Apr 23, 2019 | Arrow International Inc Arrow JACC with Chlorag+ard Technology
Product Code:JR 42563 HPHNM Terminated |
LJS | K132133 |
| Apr 23, 2019 | Arrow International Inc Arrow JACC with Chlorag+ard Technology
Product Code: JR 42541 HPHNM Terminated |
LJS | K132133 |
| Apr 23, 2019 | Arrow International Inc Arrow JACC with Chlorag+ard Technology
Product Code: JR 42063 HPHNM Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow JACC with Chlorag+ard Technology
Product Code: JR 42041 HPHNM Terminated |
LJS | K132133 |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance PICC
Product Code: CDC45541HPK1A Terminated |
LJS | K112896 |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance PICC pre loaded
with Arrow VPS" Precision Stylet
Product Code: CDC 45063 VPS2 Terminated |
LJS | K153487 |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance PICC pre loaded
with Arrow VPS" Precision Stylet
Product Code: CDC 45063 HPK1A Terminated |
LJS | K130876 |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance" PICC pre loaded with Arrow VPS" Precision Stylet
Product Code: CDC 45041 VPS2 Terminated |
LJS | K153487 |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance PICC pre loaded
with Arrow VPS" Precision Stylet
Product Code: CDC 44063 VPS2 Terminated |
LJS | K153487 |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance PICC pre loaded
with Arrow VPS" Precision Stylet
Product Code: CDC 44052 VPS2 Terminated |
LJS | K132133 |
| Apr 23, 2019 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
Product Code: CDC 44052 HPK1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow JACC with Chlorag+ard Technology Jugular Axillosubclavian Central Catheter
Product Code: CDC 43063 JX1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter
Product Code: CDC 42563 JX1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter
Product Code: CDC 42552 JX1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance JACC
Product Code: CDC 42063 JX1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance JACC
Product Code:CDC 42052 JX1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance JACC
Product Code: CDC 42041 JX1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance JACC
Product Code: CDC 41552 JX1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance JACC
Product Code: CDC 41541 JX1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
Product Code: CDA 45552 VPS2 Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
Product Code: CDA 45541 HPK1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
Product Code: CDA 45052 HPK1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
Product Code: CDA 45041 HPK1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
Product Code: CDA 44052 HPK1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC Kit
Product Code: ASK 45552 RWJ4 Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC Kit pre loaded with Arrow VPS Precision Stylet
Product Code: ASK 45552 CRM Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC Kit
Product Code: ASK 45541 RWJ4 Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC Kit
Product Code: ASK 45541 LVH1 Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC powered by Arrow VPS Stylet
Product Code: ASK45041JHVA Terminated |
LJS | None listed |
| Dec 13, 2018 | Arrow International Inc Arrow PICC powered by Arrow VPS Precision Stylet
Product Code:CDC-44052-VPS2
Product Usage:
The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central Terminated |
LJS | K153487 |
| Dec 13, 2018 | Arrow International Inc Arrow PICC powered by Arrow VPS Precision Stylet
Product Code:CDC-45052-VPS2
Product Usage:
The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central Terminated |
LJS | K153487 |
| Oct 16, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL
SYSTEM (LTP) PG) Cat. no. 60M183481 Terminated |
LJS | K121990 |
| Oct 16, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711 Terminated |
LJS | K091261 |
| Oct 1, 2018 | Medical Components, Inc dba MedComp C3 Wave App, v. 2.0.5 Terminated |
LJS | K170934 |
| Jul 17, 2018 | Arrow International Inc 5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2 Terminated |
LJS | K153487 |
| Jul 17, 2018 | Arrow International Inc 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2 Terminated |
LJS | K153487 |
| May 17, 2018 | Arrow International Inc Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW
Product Usage:
To provide real time tip location information of a central venous catheter by utilization of ECG to obse Terminated |
LJS | K963257 |
| May 17, 2018 | Arrow International Inc VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP
Product Usage:
To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip Terminated |
LJS | K160925 |
| May 17, 2018 | Arrow International Inc VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO
Product Usage:
To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip ap Terminated |
LJS | K160925 |
| May 17, 2018 | Arrow International Inc VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ
Product Usage:
To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave c Terminated |
LJS | K160925 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL XCELA PICC, Catalog Number 60M122272 Terminated |
LJS | K152409 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038 Terminated |
LJS | K163452 |
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