Venture® OTW catheter
GUDID M20658210
The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.
Vascular Solutions, Inc.
Peripheral vascular infusion catheter| Primary Device ID | M20658210 |
| NIH Device Record Key | 6bba231c-9b19-4ad3-a315-1c1717a67559 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Venture® OTW catheter |
| Version Model Number | 5821 |
| Company DUNS | 008999906 |
| Company Name | Vascular Solutions, 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
Device Dimensions
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
| Length | 140 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M20658210 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042910
FDA Product Code
| DQY | Catheter, Percutaneous |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2016-09-05 |
Devices Manufactured by Vascular Solutions, Inc.
| 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 |
Trademark Results [Venture]
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