DeviceClearance

Product code PNS— Cardiovascular

Angel Catheter

Classification name
Short-Term Intravascular Filter Catheter
Device class
Class 2
Regulation
21 CFR 870.3375
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“For short-term prevention of pulmonary embolism (PE)”

— U.S. Food and Drug Administration, device classification record for product code PNS under 21 CFR 870.3375, via openFDA

Market context for product code PNS

FDA has cleared 1 device under product code PNS, all in 2016, filed by 1 applicant company. 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.

Top applicants under product code PNS

Recent clearances under product code PNS

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