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

System, Hypothermia, Intravenous, Cooling

21 CFR 870.5900 / Cardiovascular
FDA source (opens on fda.gov)

NCX is the FDA product code for System, Hypothermia, Intravenous, Cooling, a class II device type, regulated under 21 CFR 870.5900. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 35 recalls.

Classification record

Product code
NCX
Device name
System, Hypothermia, Intravenous, Cooling
Regulation
21 CFR 870.5900
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
No
Ingested clearances
26
Ingested recalls
35

Clearances, product code NCX

By decision year
26 clearances under product code NCX with a decision year between 2002 and 2023, 2007 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code NCX by decision year
YearClearances
20021
20033
20041
20052
20061
20076
20083
20101
20141
20151
20163
20211
20221
20231

Applicants with the most clearances

Product code NCX
Applicants holding the most 510(k) clearances under product code NCX
ApplicantClearances
Alsius Corp.9
ZOLL Circulation, Inc.7
Radiant Medical4
Innercool Therapies2
Innercool Therapies, Inc.- A Delaware Corporation1
Medivance Inc.1
Novocor Medical Systems, Inc.1
Seiratherm GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code