RapidCross™
GUDID 00763000757168
PTA A14BX040150170 RAPIDCROSS V05
MEDTRONIC, INC.
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00763000757168 |
| NIH Device Record Key | aa691727-3b40-4e5c-8c46-b1e244637263 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RapidCross™ |
| Version Model Number | A14BX040150170 |
| 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 | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 Centimeter |
| Balloon Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Balloon Length | 150 Millimeter |
| Catheter Working Length | 170 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 | 00763000757168 [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.