| Primary Device ID | M20677870 |
| NIH Device Record Key | 6cea9157-177c-4c18-82c5-55ddad23b025 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VSI Basic Radiofrequency Ablation Procedure Pack with 7F 11cm Introducer Kit |
| Version Model Number | 7787 |
| Company DUNS | 008999906 |
| Company Name | Vascular Solutions, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M20677870 [Primary] |
| LRP | Tray, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-11-06 |
| Device Publish Date | 2016-09-06 |
| M20677101 - Vascular Solutions Custom Access Kit | 2023-06-09 |
| M20677141 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677181 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677191 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677201 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677211 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677221 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677231 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |