| Primary Device ID | B251MCA1 |
| NIH Device Record Key | 89e99bd6-dc7d-4f65-bc97-2b4c75747a97 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MegaVac Catheter |
| Version Model Number | ATK |
| Catalog Number | MCA |
| Company DUNS | 080210058 |
| Company Name | CAPTURE VASCULAR, 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B251MCA1 [Primary] |
| DXE | Catheter, Embolectomy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-04-07 |
| B251TWA1 - ThromboWire | 2019-03-21 The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboW |
| B251MCA1 - MegaVac Catheter | 2018-07-06The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboWire containing an embo |
| B251MCA1 - MegaVac Catheter | 2018-07-06 The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboW |
| B251MTSA2 - MegaVac Mechanical Thrombectomy System | 2018-07-06 The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboW |