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
49–72 of 302
Cleared Nov 20, 2013
NMI PICC III
K133264
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Nov 05, 2013
ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN
K132567
Covidien
General Hospital · 82d
Cleared Oct 11, 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
K132885
Cook Incorporated
General Hospital · 25d
Cleared Aug 16, 2013
6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
K131687
Medical Components, Inc.
General Hospital · 67d
Cleared Aug 16, 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
K132334
Cook, Inc.
General Hospital · 21d
Cleared Jul 31, 2013
NMI PICC III CATHETER, NMI HPICC III CATHETER
K131942
Navilyst Medical, Inc.
General Hospital · 34d
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 Dec 12, 2012
VASU-PICC
K122423
Medical Components, Inc.
General Hospital · 125d
Cleared Oct 18, 2012
NMI HPICC III
K122882
Navilyst Medical, Inc.
General Hospital · 28d
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 06, 2012
MEDCOMP VASCU-PICC & MIDLINE CATHETERS
K121094
Medical Components, Inc.
General Hospital · 57d
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 Oct 20, 2011
SAPIENS TIP CONFIRMATION SYSTEM
K112744
C.R. Bard, Inc.
General Hospital · 29d
Cleared Jul 29, 2011
XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY
K111906
Navilyst Medical, Inc.
General Hospital · 24d
Cleared Jun 14, 2011
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K111244
Cook, Inc.
General Hospital · 42d
Cleared Dec 21, 2010
2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC
K102966
Medcomp
General Hospital · 77d
Cleared Nov 17, 2010
POWERPICC SV CATHETERS
K102159
C.R. Bard, Inc.
General Hospital · 107d
Cleared Sep 02, 2010
NMI IC
K101326
Navilyst Medical, Inc.
General Hospital · 114d
Cleared Aug 27, 2010
ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
K100635
Arrow Intl., Inc.
General Hospital · 175d
Cleared Mar 25, 2010
MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519
K093406
AngioDynamics, Inc.
General Hospital · 143d