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

Transducer, Pressure, Catheter Tip

21 CFR 870.2870 / Cardiovascular
FDA source (opens on fda.gov)

DXO is the FDA product code for Transducer, Pressure, Catheter Tip, a class II device type, regulated under 21 CFR 870.2870. As of , FDA records hold 64 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
DXO
Device name
Transducer, Pressure, Catheter Tip
Regulation
21 CFR 870.2870
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
64
Ingested recalls
10

Clearances, product code DXO

By decision year
64 clearances under product code DXO with a decision year between 1979 and 2026, 1988 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code DXO by decision year
YearClearances
19792
19801
19834
19844
19851
19861
19873
19885
19895
19911
19922
19933
19942
20021
20031
20051
20061
20071
20081
20101
20111
20121
20131
20143
20152
20162
20172
20181
20194
20202
20221
20241
20251
20261

Applicants with the most clearances

Product code DXO
Applicants holding the most 510(k) clearances under product code DXO
ApplicantClearances
Millar LLC.8
Opsens Inc.6
Camino Laboratories, Inc.5
Edwards Lifesciences LLC5
Radi Medical Systems AB4
Boston Scientific Corporation3
Acist Medical Systems, Inc.2
Baxter Healthcare Corporation2
Becton Dickinson Vascular Access, Inc.2
Deseret Medical, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order