NLGClass II
Catheter, Intracardiac Mapping, High-density, Reprocessed
Cardiovascular · 21 CFR 870.1220
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).
MDR events7All time
Recalls0All time
Registered firms10Currently listed
510(k) clearances3All time
Recent MDR events
7 adverse event reports on file
- PENTARAY DAug 28, 2025InjuryMW5175361
- NAMay 30, 2025MalfunctionSterilmed, Inc.2134070-2025-00008
- NADec 6, 2024InjurySterilmed, Inc.2134070-2024-00024
- N/AOct 23, 2024MalfunctionInnovative Health, Llc.3011610434-2024-00009
- N/AOct 7, 2024MalfunctionInnovative Health, Llc.3011610434-2024-00008
- N/AJul 1, 2021InjuryInnovative Health, Llc.3011610434-2021-00012
- N/AMay 11, 2021MalfunctionInnovative Health, Llc.3011610434-2021-00010
Event type breakdown
Malfunction4
Injury3
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
10 firms currently registered for this product code
510(k) clearances
3 clearances for this product code
- Innovative Health, LLCDec 20, 2021
K212776 · Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
- Innovative Health, LLCNov 18, 2021
K211662 · Reprocessed IntellaMap Orion High Resolution Mapping Catheter
- Innovative Health, LLCJun 25, 2019
K190785 · Reprocessed PentaRay Nav eco High-Density Mapping Catheter