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

System, Balloon, Intra-Aortic And Control, Reprocessed

21 CFR 870.3535 / Cardiovascular
FDA source (opens on fda.gov)

NKO is the FDA product code for System, Balloon, Intra-Aortic And Control, Reprocessed, a class III device type, regulated under 21 CFR 870.3535. FDA's definition for this code reads: "Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NKO
Device name
System, Balloon, Intra-Aortic And Control, Reprocessed
FDA definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation
21 CFR 870.3535
Device class
Class III
Review panel
Cardiovascular
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

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