TactiFlex™ Sensor Enabled™ A-TFSE-DF
GUDID 05415067034571
Ablation Catheter
ST. JUDE MEDICAL, INC.
Cardiac radio-frequency ablation system catheter| Primary Device ID | 05415067034571 |
| NIH Device Record Key | 33fec2fe-5eec-467d-9dfc-e0182cddbd34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TactiFlex™ Sensor Enabled™ |
| Version Model Number | A-TFSE-DF |
| Catalog Number | A-TFSE-DF |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
| Length | 115 Centimeter |
| Catheter Gauge | 8 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067034571 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P220013
FDA Product Code
| OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-08 |
| Device Publish Date | 2023-05-31 |
On-Brand Devices [TactiFlex™ Sensor Enabled™]
| 05415067034694 | Ablation Catheter |
| 05415067034670 | Ablation Catheter |
| 05415067034656 | Ablation Catheter |
| 05415067034632 | Ablation Catheter |
| 05415067034618 | Ablation Catheter |
| 05415067034595 | Ablation Catheter |
| 05415067034571 | Ablation Catheter |
| 05415067034557 | Ablation Catheter |
Trademark Results [TactiFlex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TACTIFLEX 97499561 not registered Live/Pending |
St. Jude Medical, LLC 2022-07-12 |
 TACTIFLEX 88263714 not registered Live/Pending |
St. Jude Medical, LLC 2019-01-16 |
 TACTIFLEX 86365814 not registered Dead/Abandoned |
St. Jude Medical, Inc. 2014-08-13 |
 TACTIFLEX 85538371 4343484 Dead/Cancelled |
General Cable Technologies Corporation 2012-02-09 |
 TACTIFLEX 73836475 1599474 Dead/Cancelled |
MEDTRONIC, INC. 1989-11-06 |
 TACTIFLEX 73325733 1202573 Dead/Cancelled |
Bowmar Instruments Corporation 1981-08-28 |
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