WavelinQ WQ4300
GUDID 00801741189104
WavelinQ™ EndoAVF System
CLEARSTREAM TECHNOLOGIES LIMITED
Vascular guide-catheter, single-use| Primary Device ID | 00801741189104 |
| NIH Device Record Key | d532acac-5aa2-4c5c-bce1-d0fa0b08dc55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WavelinQ |
| Version Model Number | WQ4300 |
| Catalog Number | WQ4300 |
| Company DUNS | 989214291 |
| Company Name | CLEARSTREAM TECHNOLOGIES LIMITED |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741189104 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192239
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 | 2 |
| Public Version Date | 2020-03-12 |
| Device Publish Date | 2019-11-15 |
On-Brand Devices [WavelinQ]
| 00801741189104 | WavelinQ™ EndoAVF System |
| 00801741218033 | WavelinQ 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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