coraFlex
GUDID 00856492005722
Cora Flex Coronary Catheter 14X150cm
REFLOW MEDICAL, INC.
Vascular guide-catheter, single-use| Primary Device ID | 00856492005722 |
| NIH Device Record Key | 85cbdebf-8776-4302-b42a-8c3f71507733 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | coraFlex |
| Version Model Number | FLX14150US |
| Company DUNS | 962545294 |
| Company Name | REFLOW 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 | 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
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856492005722 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201811
FDA Product Code
| DQY | Catheter, Percutaneous |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-28 |
| Device Publish Date | 2020-12-18 |
On-Brand Devices [coraFlex]
| 00856492005722 | Cora Flex Coronary Catheter 14X150cm |
| 00856492005715 | Cora Flex Coronary Catheter 14X135cm |
Trademark Results [coraFlex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORAFLEX 98187395 not registered Live/Pending |
ReFlow Medical, Inc. 2023-09-19 |
 CORAFLEX 74519766 2032560 Dead/Cancelled |
JAM INDUSTRIES LTD./LTEE 1994-05-03 |
 CORAFLEX 73719501 1510025 Dead/Cancelled |
BIOCONTROL TECHNOLOGY, INC. 1988-03-29 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.