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

System, Catheter Control, Steerable

21 CFR 870.1290 / Cardiovascular
FDA source (opens on fda.gov)

DXX is the FDA product code for System, Catheter Control, Steerable, a class II device type, regulated under 21 CFR 870.1290. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
DXX
Device name
System, Catheter Control, Steerable
Regulation
21 CFR 870.1290
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
34
Ingested recalls
4

Clearances, product code DXX

By decision year
34 clearances under product code DXX with a decision year between 1990 and 2026, 2012 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code DXX by decision year
YearClearances
19901
19931
20031
20041
20061
20072
20081
20092
20101
20124
20131
20144
20154
20162
20183
20201
20221
20252
20261

Applicants with the most clearances

Product code DXX
Applicants holding the most 510(k) clearances under product code DXX
ApplicantClearances
Hansen Medical, Inc.10
Corindus, Inc.9
Stereotaxis Inc8
Catheter Research C/O Burditt, Bowles & Radzius2
Catheter Robotics, Inc.2
Hanson Medical, Inc.1
Microbot Medical Inc.1
Stereotaxis, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code