510(k) K014124

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

January 16, 2002

Date Received

December 17, 2001

Clearance Type

Special

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

Device Class

Class II

Regulation Number

870.1250

Review Panel

CV

Submission Type

Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve. Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.