Product code NKR

Device name

System, Catheter Control, Reprocessed

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.1290

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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).

Source

FDA openFDA device classification dataset