EndoCATH FG-0003-02
GUDID 30840143909409
Large Occlusion Balloon Catheter
ATRICURE, INC.
Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided| Primary Device ID | 30840143909409 |
| NIH Device Record Key | 2ba46fdd-d519-4948-bdbe-f4a5d527f527 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EndoCATH |
| Version Model Number | 20-06 |
| Catalog Number | FG-0003-02 |
| Company DUNS | 006133784 |
| Company Name | ATRICURE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com | |
| Phone | 866-449-2342 |
| SEhlert@atricure.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10840143909405 [Primary] |
| GS1 | 30840143909409 [Package] Contains: 10840143909405 Package: box [1 Units] In Commercial Distribution |
| GS1 | 50840143909403 [Package] Package: case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K070126
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 | 2023-04-14 |
| Device Publish Date | 2023-04-06 |
On-Brand Devices [EndoCATH]
| 00818354017571 | Large Occlusion Balloon Catheter |
| 30840143901700 | Large Occlusion Balloon Catheter |
| 30840143903667 | Large Occlusion Balloon Catheter |
| 30840143909409 | Large Occlusion Balloon Catheter |
Trademark Results [EndoCATH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOCATH 77160003 3686539 Live/Registered |
SentreHEART, Inc. 2007-04-18 |
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