DeviceClearance

Product code NLH— Cardiovascular

VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

Classification name
Catheter, Recording, Electrode, Reprocessed
Device class
Class 2
Regulation
21 CFR 870.1220
Advisory panel
Cardiovascular
Total cleared
70
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 NLH under 21 CFR 870.1220, via openFDA

Market context for product code NLH

FDA has cleared 70 devices under product code NLH between 2002 and 2025, 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 NLH

Recent clearances under product code NLH

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