FDA Product Code
FDA Product Code MTD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1220
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261012 | OptiMap Catheter - 60mm (OPTI-CATH2-60) | Cortex, Inc. | 2026-04-23 | Special | PDF ↗ |
| K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50) | Cortex, Inc. | 2026-03-13 | Traditional | PDF ↗ |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) | Medtronic | 2024-08-07 | Traditional | PDF ↗ |
| K241372 | Advisor HD Grid X Mapping Catheter, Sensor Enabled | ABBOTT MEDICAL | 2024-07-09 | Special | PDF ↗ |
| K231312 | 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 | Biosense Webster, Inc. | 2023-07-10 | Special | PDF ↗ |
| K223666 | Ablacath Mapping Catheter | Ablacon, Inc. | 2023-03-17 | Traditional | PDF ↗ |
| K230253 | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster, Inc. | 2023-03-02 | Special | PDF ↗ |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | Acutus Medical, Inc. | 2022-06-21 | Traditional | PDF ↗ |
| K211438 | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster, Inc. | 2022-03-18 | Traditional | PDF ↗ |
| K201806 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Sterilmed Inc. (Johnson and Johnson) | 2021-06-23 | Traditional | PDF ↗ |
| K201341 | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | 2020-09-15 | Traditional | PDF ↗ |
| K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | 2020-09-03 | Traditional | PDF ↗ |
| K201750 | Pentaray Nav eco High-Density Mapping Catheter | Biosense Webster, Inc. | 2020-08-06 | Traditional | PDF ↗ |
| K193237 | Carto Octaray Mapping Catheter with Trueref Technology | Biosense Webster, Inc. | 2020-07-31 | Traditional | PDF ↗ |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | 2018-04-23 | Traditional | PDF ↗ |
| K170819 | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | 2017-10-16 | Traditional | PDF ↗ |
| K163709 | FIRMap Catheter | Abbott Electrophysiology | 2017-02-28 | Traditional | PDF ↗ |
| K153093 | FIRMap Catheter | Abbott Electrophysiology | 2016-04-07 | Traditional | PDF ↗ |
| K142182 | FRIMAP ADAPTER CONNECTOR (MAC) | Topera, Inc. | 2014-09-09 | Special | PDF ↗ |
| K140733 | CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER | Boston Scientific Corporation | 2014-04-28 | Traditional | PDF ↗ |
| K130827 | FIRMAP CATHETER | Topera, Inc. | 2013-10-31 | Traditional | PDF ↗ |
| K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER | Biosense Webster, Inc. | 2013-03-05 | Special | PDF ↗ |
| K120425 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER | Biosense Webster, Inc. | 2012-05-24 | Traditional | PDF ↗ |
| K121006 | ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER | St Jude Medical | 2012-05-03 | Special | PDF ↗ |
| K050217 | FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) | Biosense Webster, Inc. | 2005-03-30 | Traditional | PDF ↗ |
| K021232 | CONSTELLATION CATHETERS, MODEL 8031M | Boston Scientific Corp | 2002-05-16 | Special | PDF ↗ |
| K012926 | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 | Endocardial Solutions, Inc. | 2001-09-28 | Special | PDF ↗ |
| K003782 | CONSTELLATION CATHETER, MODEL 8031 | Boston Scientific Corp | 2001-02-14 | Special | PDF ↗ |
| K000277 | CONSTELLATION CATHETERS | Boston Scientific Corp | 2000-09-26 | Special | PDF ↗ |
| K992777 | CONSTELLATION CATHETERS, MODEL 8039 | Boston Scientific Corp | 1999-11-12 | Special | PDF ↗ |
| K990795 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES | Cardiac Pathways Corp. | 1999-06-08 | Traditional | PDF ↗ |
| K983456 | ENSITE 3000 SYSTEM | Endocardial Solutions, Inc. | 1999-04-21 | Traditional | PDF ↗ |
| K983171 | CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM | Boston Scientific Corp | 1999-03-11 | Traditional | PDF ↗ |
| K982540 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT, | Cardiac Pathways Corp. | 1999-01-27 | Traditional | PDF ↗ |
Product code MTD · Class II · Cardiovascular. Data: openFDA.