WavelinQ FX-001CE
GUDID 00868260000211
WavelinQ™ 6F endoAVF System
TVA MEDICAL, INC.
Vascular guide-catheter, single-use| Primary Device ID | 00868260000211 |
| NIH Device Record Key | f77ab0a8-15ca-46bf-8fe5-273f82354e2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WavelinQ |
| Version Model Number | FX-001CE |
| Catalog Number | FX-001CE |
| Company DUNS | 018572046 |
| Company Name | TVA MEDICAL, 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 | true |
| 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
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868260000211 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN160006
FDA Product Code
| PQK | Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-01-23 |
| Device Publish Date | 2018-08-27 |
Devices Manufactured by TVA MEDICAL, INC.
| 00868260000211 - WavelinQ | 2019-01-23WavelinQ™ 6F endoAVF System |
| 00868260000211 - WavelinQ | 2019-01-23 WavelinQ™ 6F endoAVF System |
| 00868260000228 - Electrosurgical Generator | 2018-09-20 Electrosurgical Generator |
Trademark Results [WavelinQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WAVELINQ 88021599 not registered Live/Pending |
C. R. BARD, INC. 2018-06-29 |
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