LJS · Class II · 21 CFR 880.5970

FDA Product Code LJS: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

Under FDA product code LJS, long-term implanted intravascular therapeutic catheters are cleared for extended vascular access over weeks to months.

These tunneled or implanted central venous catheters provide durable, reliable access to the central venous circulation for long-term chemotherapy, parenteral nutrition, hemodialysis, and repeated blood sampling without repeated peripheral venipuncture.

LJS devices are Class II medical devices, regulated under 21 CFR 880.5970 and reviewed by the FDA General Hospital panel.

Leading manufacturers include C.R. Bard, Inc., Navilyst Medical, Inc. and Medcomp.

302
Total
302
Cleared
131d
Avg days
1983
Since
302 devices
73–96 of 302
Cleared May 15, 2013
3F PRO-PICC
K123617
Medical Components, Inc.
General Hospital · 173d
Cleared May 09, 2013
NMI PICC MAXIMAL BARRIER NURSING KITS
K131038
Navilyst Medical, Inc.
General Hospital · 24d
Cleared Apr 26, 2013
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
K130876
Arrow International, Inc.
General Hospital · 28d
Cleared Mar 08, 2013
UNI-PICC
K130034
Health Line International Corporation
General Hospital · 60d
Cleared Jan 03, 2013
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
K123759
Arrow International, Inc. (Subsidiary of Teleflex
General Hospital · 27d
Cleared Dec 12, 2012
VASU-PICC
K122423
Medical Components, Inc.
General Hospital · 125d
Cleared Nov 29, 2012
ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)
K121501
Arrow International (Subsidiary of Teleflex Inc.)
General Hospital · 192d
Cleared Nov 06, 2012
NYLUS PICC
K113225
Semprus Biosciences
General Hospital · 371d
Cleared Oct 18, 2012
NMI HPICC III
K122882
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Sep 20, 2012
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
K122545
Arrow International (Subsidiary of Teleflex Inc.)
General Hospital · 30d
Cleared Sep 07, 2012
ARROW PICC POWERED BY ARROW VPS STYLET
K121941
Arrow International (Subsidiary of Teleflex Inc.)
General Hospital · 67d
Cleared Aug 23, 2012
NMI PICC III
K121089
Navilyst Medical, Inc.
General Hospital · 135d
Cleared Aug 03, 2012
PICC CONVENIENCE KIT
K121990
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Jun 21, 2012
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
K113277
Arrow International, Inc.
General Hospital · 227d
Cleared Jun 06, 2012
MEDCOMP VASCU-PICC & MIDLINE CATHETERS
K121094
Medical Components, Inc.
General Hospital · 57d
Cleared May 10, 2012
ARRW EVOLUTION
K112896
Arrow International (Subsidiary of Teleflex Inc.)
General Hospital · 223d
Cleared May 02, 2012
1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC
K120980
Medical Components, Inc.
General Hospital · 30d
Cleared May 02, 2012
2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC
K120981
Medical Components, Inc.
General Hospital · 30d
Cleared Mar 19, 2012
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
K113808
C.R. Bard, Inc.
General Hospital · 87d
Cleared Dec 20, 2011
DIRECT ANTIBIOTIC INFUSION KIT
K113043
Summit Medical Products, Inc.
General & Plastic Surgery · 68d
Cleared Oct 20, 2011
SAPIENS TIP CONFIRMATION SYSTEM
K112744
C.R. Bard, Inc.
General Hospital · 29d
Cleared Sep 21, 2011
TRIPLE LUMEN PFM PICC
K110914
Pfm Medical, Inc.
General Hospital · 173d
Cleared Aug 12, 2011
NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER
K110627
Marvao Medical Devices, Ltd.
General Hospital · 161d
Cleared Jul 29, 2011
XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY
K111906
Navilyst Medical, Inc.
General Hospital · 24d