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

Catheter, Embolectomy

21 CFR 870.5150 / Cardiovascular
FDA source (opens on fda.gov)

DXE is the FDA product code for Catheter, Embolectomy, a class II device type, regulated under 21 CFR 870.5150. As of , FDA records hold 74 510(k) clearances under this code, the most recent dated , and 57 recalls.

Classification record

Product code
DXE
Device name
Catheter, Embolectomy
Regulation
21 CFR 870.5150
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
74
Ingested recalls
57

Clearances, product code DXE

By decision year
74 clearances under product code DXE with a decision year between 1976 and 2024, 1998 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code DXE by decision year
YearClearances
19761
19772
19782
19791
19801
19811
19821
19832
19841
19851
19861
19874
19881
19895
19905
19913
19921
19932
19941
19951
19964
19974
19987
19991
20003
20011
20022
20031
20081
20102
20151
20172
20201
20211
20221
20245

Applicants with the most clearances

Product code DXE
Applicants holding the most 510(k) clearances under product code DXE
ApplicantClearances
Edwards Lifesciences LLC6
Shiley, Inc.5
Applied Medical Resources Corp4
Cathlab Corp.4
Ideas for Medicine, Inc.4
Lucas Medical, Inc.4
Vascutech, Inc.4
Atrium Medical Corporation3
J-Lloyd Medical, Inc.3
Applied Vascular Devices, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order