Product code NLG— Cardiovascular
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
- Classification name
- Catheter, Intracardiac Mapping, High-Density, Reprocessed
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- 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).”
Market context for product code NLG
FDA has cleared devices under product code NLG between 2019 and 2021, 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.
Clearances per year
- 2021
- 2019
Top applicants under product code NLG
Recent clearances under product code NLG
Data sourced from openFDA. This site is unofficial and independent of the FDA.