Product code DQP

Device name

Kit, Balloon Repair, Catheter

Medical specialty

Cardiovascular

Device class

3

Regulation number

870.1350

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))

Source

FDA openFDA device classification dataset