Advisor HD Grid Mapping Catheter, Sensor Enabled
510(k) K172393
Advisor HD Grid Mapping Catheter, Sensor Enabled is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K172393 on 23 Apr 2018, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172393 | Date23 Apr 2018 | StatusActive |
Official records
- FDA 510(k) database K172393
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MTD
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1220
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K172393
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Advisor™ HD Grid, Sensor Enabled™ D-AVHD-DF16 | D-AVHD-DF16 / D-AVHD-DF16 | 05415067028198 | Length 110.0000 cm; Catheter Gauge 8.0000 Fr | On the market |
Similar devices
Other devices filed under FDA product code MTD (Catheter, Intracardiac Mapping, High-Density Array).
- FIRMap Catheter by Abbott Electrophysiology
- ENSITE 3000 SYSTEM by Endocardial Solutions, Inc.
- CONSTELLATION CATHETERS, MODEL 8031M by Boston Scientific
- PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID by Biosense Webster Inc
- MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES by Cardiac Pathways Corp.
- OPTRELL Mapping Catheter with TRUEref Technology D142902 by Biosense Webster Inc
- CONSTELLATION CATHETERS by Boston Scientific
- Advisor HD Grid X Mapping Catheter, Sensor Enabled by Abbott Medical
- OptiMap Catheter - 50mm (OPTI-CATH2-50) by Cortex, Inc.
- Sphere-9Dx Diagnostic Catheter (AFR-00009) by MEDTRONIC, INC.