Catheter, Intracardiac Mapping, High-Density, Reprocessed
The Reprocessed High-Density Intracardiac Mapping Catheter is a reprocessed cardiovascular electrophysiology device used to map electrical activity within the heart at high spatial density to guide ablation and other arrhythmia treatments; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NLG and regulation 21 CFR 870.1220 in the Cardiovascular specialty. The device is not an implant and is not life-sustaining.
Basic Information
- Product Code
- NLG
- Device Class
- FDA class 2
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Dec 20, 2021 | Substantially Equivalent | Innovative Health, LLC |
| K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | Nov 18, 2021 | Substantially Equivalent | Innovative Health, LLC |
| K190785 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Jun 25, 2019 | Substantially Equivalent | Innovative Health, LLC |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.