Direxion™ HI-FLO™ Fathom™-16 System M001195970
GUDID 08714729991076
Pre-Loaded Torqueable Microcatheter
BOSTON SCIENTIFIC CORPORATION
Vascular microcatheter| Primary Device ID | 08714729991076 |
| NIH Device Record Key | 6a357ba1-0929-4ace-9978-f93c334ceafc |
| Commercial Distribution Discontinuation | 2021-09-24 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Direxion™ HI-FLO™ Fathom™-16 System |
| Version Model Number | M001195970 |
| Catalog Number | M001195970 |
| Company DUNS | 021717889 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| 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 | 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 Dimensions
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
| Catheter Working Length | 155 Centimeter |
| Guidewire Length | 200 Centimeter |
| Catheter Inner Diameter | 0.027 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08714729991076 [Primary] |
FDA Product Code
| KRA | Catheter, continuous flush |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-09-25 |
| Device Publish Date | 2019-07-18 |
On-Brand Devices [Direxion™ HI-FLO™ Fathom™-16 System]
| 08714729991076 | Pre-Loaded Torqueable Microcatheter |
| 08714729991069 | Pre-Loaded Torqueable Microcatheter |
Trademark Results [Direxion]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIREXION 85717234 4515484 Live/Registered |
Boston Scientific Scimed, Inc. 2012-08-30 |
 DIREXION 77617332 3642901 Live/Registered |
Rafferty Asset Management, LLC 2008-11-19 |
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