DeviceClearance

Product code DWM— Cardiovascular

ASPIRA PLEURAL DRAINAGE SYSTEM

Classification name
Apparatus, Suction, Patient Care
Device class
Class 2
Regulation
21 CFR 870.5050
Advisory panel
Cardiovascular
Total cleared
19
First cleared
Most recent

Market context for product code DWM

FDA has cleared 19 devices under product code DWM between 1981 and 2023, filed by 10 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

last 15 years

Top applicants under product code DWM

Adverse events under product code DWM

product code DWM
Death
8
Total
8

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code DWM

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