Product code DWD— Cardiovascular

AJDJUSTABLE SUCTION CONTROL VALVE

Classification name
Suction Control, Intracardiac, Cardiopulmonary Bypass
Device class
Class 2
Regulation
21 CFR 870.4430
Advisory panel
Cardiovascular
Total cleared
15
First cleared
Most recent

Market context for product code DWD

FDA has cleared 15 devices under product code DWD between 1976 and 2000, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code DWD

Recent clearances under product code DWD

Data sourced from openFDA. This site is unofficial and independent of the FDA.