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

Catheter, Angioplasty, Peripheral, Transluminal

21 CFR 870.1250 / Cardiovascular
FDA source (opens on fda.gov)

LIT is the FDA product code for Catheter, Angioplasty, Peripheral, Transluminal, a class II device type, regulated under 21 CFR 870.1250. As of , FDA records hold 403 510(k) clearances under this code, the most recent dated , and 32 recalls.

Classification record

Product code
LIT
Device name
Catheter, Angioplasty, Peripheral, Transluminal
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
405
Ingested recalls
32

Clearances, product code LIT

By decision year
405 clearances under product code LIT with a decision year between 1981 and 2026, 1991 the highest year at 26.
Show the numbers
510(k) clearances under FDA product code LIT by decision year
YearClearances
19813
19821
19837
19847
19858
19863
19874
198812
19898
199018
199126
199214
199317
199419
199512
19967
199717
19988
19995
200014
20011
20023
20032
20042
20056
20063
20076
20088
20097
201013
201110
201219
201314
201412
201519
201611
20179
20186
20194
20209
20214
20228
20236
20246
20253
20264

Applicants with the most clearances

Product code LIT
Applicants holding the most 510(k) clearances under product code LIT
ApplicantClearances
Boston Scientific Corporation59
Cordis US Corp.31
Meadox Medicals, Div. Boston Scientific Corp.14
Vas-Cath, Inc.14
C.R. Bard Inc13
Medtronic, Inc.13
Scimed Life Systems, Inc.13
Cook Inc.12
Advanced Cardiovascular Systems, Inc.10
BIOTRONIK AG10

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 71 companies shown, in name order