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

Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed

21 CFR 870.1650 / Cardiovascular
FDA source (opens on fda.gov)

NKU is the FDA product code for Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed, a class II device type, regulated under 21 CFR 870.1650. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
NKU
Device name
Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
Regulation
21 CFR 870.1650
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
1
Ingested recalls
1

Clearances, product code NKU

By decision year
1 clearance under product code NKU with a decision year between 2006 and 2006, 2006 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NKU by decision year
YearClearances
20061

Applicants with the most clearances

Product code NKU
Applicants holding the most 510(k) clearances under product code NKU
ApplicantClearances
Sterilmed Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

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