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

Gauge, Pressure, Coronary, Cardiopulmonary Bypass

21 CFR 870.4310 / Cardiovascular
FDA source (opens on fda.gov)

DXS is the FDA product code for Gauge, Pressure, Coronary, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4310. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
DXS
Device name
Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Regulation
21 CFR 870.4310
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
13
Ingested recalls
5

Clearances, product code DXS

By decision year
13 clearances under product code DXS with a decision year between 1977 and 2011, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DXS by decision year
YearClearances
19771
19781
19822
19831
19841
19851
19861
19871
19901
19911
19941
20111

Applicants with the most clearances

Product code DXS
Applicants holding the most 510(k) clearances under product code DXS
ApplicantClearances
Delta Medical Industries3
Shiley, Inc.2
3M Health Care, Sarns1
American Omni Medical, Inc.1
Dlp, Inc.1
Gambro, Inc.1
Lifestream Int'L, Inc.1
Medtronic, Inc.1
Norton Texas Medical Products1
Vascular Technology Incorporated1

Companies listing this code with FDA

Companies whose registered establishments list this code