Product code OAD
- Device name
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- For the treatment of atrial flutter.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P110016S093 | FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE) | ABBOTT MEDICAL | 2026-04-09 |
| P110016S092 | FlexAbility™ and FlexAbility™ Sensor Enabled™ | ABBOTT MEDICAL | 2026-01-15 |
| P040042S058 | Safire™ TX Bi-directional and Therapy™ Dual-8™ | Irvine Biomedical,Inc.(Ibi) | 2026-01-15 |
| P110016S091 | FlexAbility™ Ablation Catheter (Flex) and FlexAbility™ Ablation Catheter, Sensor Enabled™ (Flex SE) | ABBOTT MEDICAL | 2026-01-08 |
| P060019S058 | Cool Point™ Tubing Set | Irvine Biomedical, Inc. | 2025-12-19 |
| P150005S090 | Intellagen™ Irrigation Tubing Set | Boston Scientific Corp | 2025-12-05 |
| P150005S091 | RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) (M004RA65010); Rhythmia HDx™ Ablation Connection Box (Maestro™) | Boston Scientific Corp | 2025-10-17 |
| P020025S147 | RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) (M004RA65010); Rhythmia HDx™ Ablation Connection Box (Maestro™) | Boston Scientific | 2025-10-17 |
| P110016S089 | FlexAbility™ Ablation Catheter, Sensor Enabled™ | ABBOTT MEDICAL | 2025-10-16 |
| P150005S088 | Opal HDx Ablation Connection Box (Maestro); Opal HDx Ablation Connection Box - IntellaNav StablePoint; Opal HDx Ablation | Boston Scientific Corp | 2025-09-02 |
| P150005S089 | Blazer™ Open-Irrigated Ablation Catheter | Boston Scientific Corp | 2025-08-14 |
| P020025S146 | Blazer™ II XP Cardiac Ablation Catheter and Cable | Boston Scientific | 2025-08-14 |
| P060019S057 | IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF | Irvine Biomedical, Inc. | 2025-05-28 |
| P110016S090 | FlexAbility™ Ablation Catheter, Sensor Enabled™ | ABBOTT MEDICAL | 2025-05-06 |
| P110016S088 | FlexAbility™ Ablation Catheter; FlexAbility™ Ablation Catheter, Sensor Enabled™ | ABBOTT MEDICAL | 2025-04-10 |
| P040042S057 | Safire TX Ablation Catheter; Safire TX, Catheter Extension Cable; Therapy 8mm Tip Thermistor Ablation Catheter; Therapy | Irvine Biomedical,Inc.(Ibi) | 2025-04-10 |
| P150005S087 | RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™);RHYTHMIA HDx™ | Boston Scientific Corp | 2025-03-31 |
| P020025S145 | RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™) | Boston Scientific | 2025-03-31 |
| P020025S144 | IntellaNav MiFi XP Ablation Catheter | Boston Scientific | 2025-03-20 |
| P030031S138 | Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) | Biosense Webster, Inc. | 2025-02-26 |
| P010068S074 | Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) | Biosense Webster, Inc. | 2025-02-26 |
| P030031S139 | Navistar Thermocool Catheter; Thermocool SmartTouch Catheter; Thermocool SmartTouch SF Catheter; Thermocool SF NAV Cathe | Biosense Webster, Inc. | 2025-02-25 |
| P010068S075 | NAVISTAR DS Electrophysiology Catheter | Biosense Webster, Inc. | 2025-02-25 |
| P110016S087 | FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE) | ABBOTT MEDICAL | 2024-12-13 |
| P030031S137 | NAVISTAR RMT Thermocool Electrophysiology Catheter, EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, T | Biosense Webster, Inc. | 2024-11-20 |
| P010068S073 | EZ Steer NAV DS Bi-Directional Electrophysiology Catheter, NAVISTAR DS Electrophysiology Catheter | Biosense Webster, Inc. | 2024-11-20 |
| P030031S135 | nMARQ Catheter Interference Cable | Biosense Webster, Inc. | 2024-11-15 |
| P010068S072 | nMARQ Catheter Interference Cable | Biosense Webster, Inc. | 2024-11-15 |
| P150005S086 | Blazer Open Irrigated Ablation Catheter, IntellaNav Open Irrigated Ablation Catheter, IntellaNav MiFi Open Irrigated Abl | Boston Scientific Corp | 2024-11-14 |
| P040042S056 | Safire™ TX Ablation Catheter, Safire™ TX, Catheter Extension Cable, Therapy™ Dual-8™ Ablation Catheter, Cables 16- 17- 1 | Irvine Biomedical,Inc.(Ibi) | 2024-10-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000954321 | NA | MEDTRONIC, INC. | 2026-04-30 |
| 00199150003709 | Sphere-9™ Catheter | MEDTRONIC, INC. | 2026-02-20 |
| 00763000993269 | Sphere-9™ Catheter | MEDTRONIC, INC. | 2026-02-08 |
| 00763000998332 | HexaFlow™ Irrigation Pump | MEDTRONIC, INC. | 2025-08-30 |
| 00763000998301 | HexaGen™ RF Generator | MEDTRONIC, INC. | 2025-08-30 |
| 00763000995003 | N/A | MEDTRONIC, INC. | 2025-04-12 |
| 00763000973391 | Sphere-9™ Catheter | MEDTRONIC, INC. | 2024-12-06 |
| 00763000871925 | HexaPulse™ PF Generator | MEDTRONIC, INC. | 2024-11-04 |
| 00763000871895 | HexaFlow™ Irrigation Pump | MEDTRONIC, INC. | 2024-11-04 |
| 00763000871864 | HexaGen™ RF Generator | MEDTRONIC, INC. | 2024-11-04 |
| 00763000871802 | NA | MEDTRONIC, INC. | 2024-11-04 |
| 00763000871772 | NA | MEDTRONIC, INC. | 2024-11-04 |
| 08714729992233 | INTELLANAV STABLEPOINT™ | BOSTON SCIENTIFIC CORPORATION | 2024-02-29 |
| 08714729992240 | INTELLANAV STABLEPOINT™ | BOSTON SCIENTIFIC CORPORATION | 2024-02-29 |
| 10846835017076 | QDOT MICRO | Biosense Webster Inc | 2023-07-07 |
| 10846835017106 | QDOT MICRO | Biosense Webster Inc | 2023-07-07 |
| 10846835016710 | QDOT MICRO | Biosense Webster Inc | 2023-07-07 |
| 10846835018080 | nGEN Generator | Biosense Webster Inc | 2022-08-18 |
| 08714729861935 | Maestro 4000™ Controller | BOSTON SCIENTIFIC CORPORATION | 2018-03-19 |
| 08714729862116 | MetriQ™ Pump | BOSTON SCIENTIFIC CORPORATION | 2018-03-16 |
| 08714729862109 | MetriQ™ Pump | BOSTON SCIENTIFIC CORPORATION | 2018-01-17 |
| 08714729862123 | MetriQ™ Pump | BOSTON SCIENTIFIC CORPORATION | 2017-11-14 |
| 08714729861928 | Maestro 4000™ Controller | BOSTON SCIENTIFIC CORPORATION | 2017-11-06 |
| 08714729774440 | Maestro™ Remote Control Cable -50' | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729854395 | IntellaTip MiFi™ Filter Module | BOSTON SCIENTIFIC CORPORATION | 2016-08-08 |
| 08714729862260 | MetriQ™ Pump | BOSTON SCIENTIFIC CORPORATION | 2016-03-14 |
| 08714729862147 | MetriQ™ Foot Switch | BOSTON SCIENTIFIC CORPORATION | 2016-03-14 |
| 08714729861966 | Maestro 4000™ Pod, 100W | BOSTON SCIENTIFIC CORPORATION | 2015-01-27 |
| 08714729861911 | Maestro 4000™ Controller | BOSTON SCIENTIFIC CORPORATION | 2015-01-27 |
| 08714729270010 | Recording System EGM Cable | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |