EkoSonic® 500-55118
GUDID 00858593006141
The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic Core. The device delivers physician-specified fluids and ultrasound to the intravascular treatment site. It comes in different working lengths and treatment zones.
EKOS CORPORATION
Ultrasound thrombolysis system catheter, pulmonary| Primary Device ID | 00858593006141 |
| NIH Device Record Key | 60eb68eb-7763-41da-91e1-3dd8d68ea859 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EkoSonic® |
| Version Model Number | 6779-003 |
| Catalog Number | 500-55118 |
| Company DUNS | 943488429 |
| Company Name | EKOS 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 | false |
| Serial Number | true |
| 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 | 106 Centimeter |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
| Device Size Text, specify | 0 |
| Length | 106 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858593006141 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140151
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 | 4 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [EkoSonic®]
| 00858593006509 | The Connector Interface Cable (CIC) is the cable assembly that connects the Infusion Catheter an |
| 00858593006493 | The EkoSonic® Control Unit provides power to the Ultrasonic Core and monitors parameters during |
| 00858593006318 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006301 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006295 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006264 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006189 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006172 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006165 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006158 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006141 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006134 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006028 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
Trademark Results [EkoSonic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EKOSONIC 77569254 3608703 Live/Registered |
EKOS Corporation 2008-09-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.