DeviceClearance

Product code NMF— Cardiovascular

REPROCESSED FEMORAL COMPRESSION DEVICE

Classification name
Clamp, Vascular, Reprocessed
Device class
Class 2
Regulation
21 CFR 870.4450
Advisory panel
Cardiovascular
Total cleared
3
First cleared
Most recent

FDA classification definition

“Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).”

— U.S. Food and Drug Administration, device classification record for product code NMF under 21 CFR 870.4450, via openFDA

Market context for product code NMF

FDA has cleared 3 devices under product code NMF between 2001 and 2012, filed by 2 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 NMF

Recent clearances under product code NMF

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