DeviceClearance

Product code MWS— Cardiovascular

HEART-LIFT BALLOON POSITIONER

Classification name
Stabilizer, Heart
Device class
Class 1
Regulation
21 CFR 870.4500
Advisory panel
Cardiovascular
Total cleared
4
First cleared
Most recent

Market context for product code MWS

FDA has cleared 4 devices under product code MWS between 1999 and 2004, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code MWS

Adverse events under product code MWS

product code MWS
Death
4
Total
4

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 MWS

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