PulseSelect™
GUDID 00763000617554
CATHETER PSCC100 PULSESELECT US 25MM
MEDTRONIC, INC.
Cardiac irreversible electroporation system catheter| Primary Device ID | 00763000617554 |
| NIH Device Record Key | 4dff35c2-4fb0-4b5d-bc29-f35a6dfcaf55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PulseSelect™ |
| Version Model Number | PSCC100 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, 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 | false |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 99 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Length | 145 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000617554 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P230017
FDA Product Code
| QZI | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation |
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 | 2024-02-16 |
| Device Publish Date | 2024-02-08 |
On-Brand Devices [PulseSelect™]
| 00763000617752 | REMOTE CONTROL PSRC101 PFA 25FT US |
| 00763000617745 | REMOTE CONTROL PSRC100 PFA 10 FT US |
| 00763000617530 | GENERATOR PSG100 PULSESELECT US |
| 00763000617554 | CATHETER PSCC100 PULSESELECT US 25MM |
| 00763000617783 | FOOTSWITCH PSFS100 PFA US |
| 00763000617592 | CABLE PSCIC101 CATHETER PFA US |
| 00763000617578 | CABLE PSEGM100 EGM US |
| 00763000897215 | GENERATOR PSG100 PULSESELECT LOANER US |
Trademark Results [PulseSelect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PULSESELECT 88747739 not registered Live/Pending |
Medtronic Inc. 2020-01-06 |
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