510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LJSClass II

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

21 CFR 880.5970 / General Hospital
FDA source (opens on fda.gov)

LJS is the FDA product code for Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, a class II device type, regulated under 21 CFR 880.5970. As of , FDA records hold 302 510(k) clearances under this code, the most recent dated , and 332 recalls.

Classification record

Product code
LJS
Device name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
302
Ingested recalls
332

Clearances, product code LJS

By decision year
302 clearances under product code LJS with a decision year between 1983 and 2026, 1984 the highest year at 17.
Show the numbers
510(k) clearances under FDA product code LJS by decision year
YearClearances
19838
198417
19852
19862
19872
19883
19893
19904
19915
19921
19936
199411
199515
199613
199711
19982
19991
20008
20015
20022
20036
200411
200512
200612
200714
20084
200916
20109
20116
201214
201314
20148
20157
20169
20177
201810
20202
20213
20223
20234
20241
20258
20261

Applicants with the most clearances

Product code LJS
Applicants holding the most 510(k) clearances under product code LJS
ApplicantClearances
C.R. Bard Inc34
Boston Scientific Corporation31
Medcomp11
Medical Components, Inc.11
Strato Medical Corp.8
Pharmacia Deltec, Inc.7
Access Vascular, Inc6
Arrow Intl., Inc.6
Bard Access Systems, Inc.6
L & z US, Inc.6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 73 companies shown, in name order