DeviceClearance

Product code DWB— Cardiovascular

ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,

Classification name
Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device class
Class 2
Regulation
21 CFR 870.4370
Advisory panel
Cardiovascular
Total cleared
21
First cleared
Most recent

Market context for product code DWB

FDA has cleared 21 devices under product code DWB between 1978 and 2016, filed by 14 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 DWB

Adverse events under product code DWB

product code DWB
Death
2
Total
2

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 DWB

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