EverCross™
GUDID 00763000766726
PTA AB35W07040135 EVERCROSS 035 V10
MEDTRONIC, INC.
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00763000766726 |
| NIH Device Record Key | 8fe655aa-6275-4b7a-91d6-ecacaa0b566f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EverCross™ |
| Version Model Number | AB35W07040135 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, 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 | false |
| 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 | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 135 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000766726 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190753
FDA Product Code
| LIT | Catheter, angioplasty, peripheral, transluminal |
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 | 2024-03-15 |
| Device Publish Date | 2024-03-07 |
On-Brand Devices [EverCross™]
| 00763000767228 | PTA AB35W12060135 EVERCROSS 035 V10 |
| 00763000767211 | PTA AB35W12060080 EVERCROSS 035 V10 |
| 00763000767204 | PTA AB35W12040135 EVERCROSS 035 V10 |
| 00763000767198 | PTA AB35W12040080 EVERCROSS 035 V10 |
| 00763000767181 | PTA AB35W12020135 EVERCROSS 035 V10 |
| 00763000767174 | PTA AB35W12020080 EVERCROSS 035 V10 |
| 00763000767167 | PTA AB35W10060135 EVERCROSS 035 V10 |
| 00763000767150 | PTA AB35W10060080 EVERCROSS 035 V10 |
| 00763000767143 | PTA AB35W10040135 EVERCROSS 035 V10 |
| 00763000767136 | PTA AB35W10040080 EVERCROSS 035 V10 |
| 00763000767129 | PTA AB35W10030135 EVERCROSS 035 V10 |
| 00763000767112 | PTA AB35W10030080 EVERCROSS 035 V10 |
| 00763000767105 | PTA AB35W10020135 EVERCROSS 035 V10 |
| 00763000767099 | PTA AB35W10020080 EVERCROSS 035 V10 |
| 00763000767082 | PTA AB35W09080135 EVERCROSS 035 V10 |
| 00763000767075 | PTA AB35W09080080 EVERCROSS 035 V10 |
| 00763000767068 | PTA AB35W09060135 EVERCROSS 035 V10 |
| 00763000767051 | PTA AB35W09060080 EVERCROSS 035 V10 |
| 00763000767044 | PTA AB35W09040135 EVERCROSS 035 V10 |
| 00763000767037 | PTA AB35W09040080 EVERCROSS 035 V10 |
| 00763000767020 | PTA AB35W09030135 EVERCROSS 035 V10 |
| 00763000767013 | PTA AB35W09030080 EVERCROSS 035 V10 |
| 00763000767006 | PTA AB35W09020135 EVERCROSS 035 V10 |
| 00763000766993 | PTA AB35W09020080 EVERCROSS 035 V10 |
| 00763000766986 | PTA AB35W08080135 EVERCROSS 035 V10 |
| 00763000766979 | PTA AB35W08080080 EVERCROSS 035 V10 |
| 00763000766962 | PTA AB35W08060135 EVERCROSS 035 V10 |
| 00763000766955 | PTA AB35W08060080 EVERCROSS 035 V10 |
| 00763000766948 | PTA AB35W08060040 EVERCROSS 035 V10 |
| 00763000766931 | PTA AB35W08040135 EVERCROSS 035 V10 |
| 00763000766924 | PTA AB35W08040080 EVERCROSS 035 V10 |
| 00763000766917 | PTA AB35W08040040 EVERCROSS 035 V10 |
| 00763000766900 | PTA AB35W08030135 EVERCROSS 035 V10 |
| 00763000766894 | PTA AB35W08030080 EVERCROSS 035 V10 |
| 00763000766887 | PTA AB35W08020135 EVERCROSS 035 V10 |
| 00763000766870 | PTA AB35W08020080 EVERCROSS 035 V10 |
| 00763000766863 | PTA AB35W08020040 EVERCROSS 035 V10 |
| 00763000766856 | PTA AB35W07200135 EVERCROSS 035 V10 |
| 00763000766849 | PTA AB35W07200080 EVERCROSS 035 V10 |
| 00763000766832 | PTA AB35W07150135 EVERCROSS 035 V10 |
| 00763000766825 | PTA AB35W07150080 EVERCROSS 035 V10 |
| 00763000766818 | PTA AB35W07120135 EVERCROSS 035 V10 |
| 00763000766801 | PTA AB35W07120080 EVERCROSS 035 V10 |
| 00763000766795 | PTA AB35W07100135 EVERCROSS 035 V10 |
| 00763000766788 | PTA AB35W07100080 EVERCROSS 035 V10 |
| 00763000766771 | PTA AB35W07080135 EVERCROSS 035 V10 |
| 00763000766764 | PTA AB35W07080080 EVERCROSS 035 V10 |
| 00763000766757 | PTA AB35W07060135 EVERCROSS 035 V10 |
| 00763000766740 | PTA AB35W07060080 EVERCROSS 035 V10 |
| 00763000766733 | PTA AB35W07060040 EVERCROSS 035 V10 |
Trademark Results [EverCross]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVERCROSS 88753781 not registered Live/Pending |
Shenzhen Yun Tongda Technology&Service Co., Ltd. 2020-01-10 |
 EVERCROSS 86434070 4862070 Live/Registered |
Covidien, LP 2014-10-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.