RapidCross™
GUDID 00763000757175
PTA A14BX040210090 RAPIDCROSS V05
MEDTRONIC, INC.
Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00763000757175 |
| NIH Device Record Key | aefefc1f-7c09-4b50-b488-4a9dcc1042b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RapidCross™ |
| Version Model Number | A14BX040210090 |
| 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
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 210 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 90 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 | 00763000757175 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130911
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 [RapidCross™]
| 00763000757182 | PTA A14BX040210170 RAPIDCROSS V05 |
| 00763000757175 | PTA A14BX040210090 RAPIDCROSS V05 |
| 00763000757168 | PTA A14BX040150170 RAPIDCROSS V05 |
| 00763000757151 | PTA A14BX040150090 RAPIDCROSS V05 |
| 00763000757144 | PTA A14BX040120170 RAPIDCROSS V05 |
| 00763000757137 | PTA A14BX040120090 RAPIDCROSS V05 |
| 00763000757120 | PTA A14BX040100170 RAPIDCROSS V05 |
| 00763000757113 | PTA A14BX040100090 RAPIDCROSS V05 |
| 00763000757106 | PTA A14BX040080170 RAPIDCROSS V05 |
| 00763000757090 | PTA A14BX040080090 RAPIDCROSS V05 |
| 00763000757083 | PTA A14BX040060170 RAPIDCROSS V05 |
| 00763000757076 | PTA A14BX040060090 RAPIDCROSS V05 |
| 00763000757069 | PTA A14BX040040170 RAPIDCROSS V05 |
| 00763000757052 | PTA A14BX040040090 RAPIDCROSS V05 |
| 00763000757045 | PTA A14BX040020170 RAPIDCROSS V05 |
| 00763000757038 | PTA A14BX040020090 RAPIDCROSS V05 |
| 00763000757021 | PTA A14BX035210170 RAPIDCROSS V05 |
| 00763000757014 | PTA A14BX035210090 RAPIDCROSS V05 |
| 00763000757007 | PTA A14BX035150170 RAPIDCROSS V05 |
| 00763000756994 | PTA A14BX035150090 RAPIDCROSS V05 |
| 00763000756987 | PTA A14BX035120170 RAPIDCROSS V05 |
| 00763000756970 | PTA A14BX035120090 RAPIDCROSS V05 |
| 00763000756963 | PTA A14BX035100170 RAPIDCROSS V05 |
| 00763000756956 | PTA A14BX035100090 RAPIDCROSS V05 |
| 00763000756949 | PTA A14BX035080170 RAPIDCROSS V05 |
| 00763000756932 | PTA A14BX035080090 RAPIDCROSS V05 |
| 00763000756925 | PTA A14BX035060170 RAPIDCROSS V05 |
| 00763000756918 | PTA A14BX035060090 RAPIDCROSS V05 |
| 00763000756901 | PTA A14BX035040170 RAPIDCROSS V05 |
| 00763000756895 | PTA A14BX035040090 RAPIDCROSS V05 |
| 00763000756888 | PTA A14BX035020170 RAPIDCROSS V05 |
| 00763000756871 | PTA A14BX035020090 RAPIDCROSS V05 |
| 00763000756864 | PTA A14BX030210170 RAPIDCROSS V05 |
| 00763000756857 | PTA A14BX030210090 RAPIDCROSS V05 |
| 00763000756840 | PTA A14BX030150170 RAPIDCROSS V05 |
| 00763000756833 | PTA A14BX030150090 RAPIDCROSS V05 |
| 00763000756826 | PTA A14BX030120170 RAPIDCROSS V05 |
| 00763000756819 | PTA A14BX030120090 RAPIDCROSS V05 |
| 00763000756802 | PTA A14BX030100170 RAPIDCROSS V05 |
| 00763000756796 | PTA A14BX030100090 RAPIDCROSS V05 |
| 00763000756789 | PTA A14BX030080170 RAPIDCROSS V05 |
| 00763000756772 | PTA A14BX030080090 RAPIDCROSS V05 |
| 00763000756765 | PTA A14BX030060170 RAPIDCROSS V05 |
| 00763000756758 | PTA A14BX030060090 RAPIDCROSS V05 |
| 00763000756741 | PTA A14BX030040170 RAPIDCROSS V05 |
| 00763000756734 | PTA A14BX030040090 RAPIDCROSS V05 |
| 00763000756727 | PTA A14BX030020170 RAPIDCROSS V05 |
| 00763000756710 | PTA A14BX030020090 RAPIDCROSS V05 |
| 00763000756703 | PTA A14BX025210170 RAPIDCROSS V05 |
| 00763000756697 | PTA A14BX025210090 RAPIDCROSS V05 |
Trademark Results [RapidCross]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RAPIDCROSS 85842611 4507467 Live/Registered |
Covidien LP 2013-02-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.