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

Sensor, Pressure, Aneurysm, Implantable

21 CFR 870.2855 / Cardiovascular
FDA source (opens on fda.gov)

NQH is the FDA product code for Sensor, Pressure, Aneurysm, Implantable, a class II device type, regulated under 21 CFR 870.2855. FDA's definition for this code reads: "This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NQH
Device name
Sensor, Pressure, Aneurysm, Implantable
FDA definition
This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.
Regulation
21 CFR 870.2855
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code NQH

By decision year
5 clearances under product code NQH with a decision year between 2005 and 2008, 2007 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NQH by decision year
YearClearances
20051
20061
20072
20081

Applicants with the most clearances

Product code NQH
Applicants holding the most 510(k) clearances under product code NQH
ApplicantClearances
Cardiomems, Inc.5

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NQH.