RapidCross™
GUDID 00763000111052
PTA A14BX035020170 RAPIDCROSS V04
Covidien LP
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00763000111052 |
| NIH Device Record Key | c1fb9318-a9fa-4528-aa59-3e325ec03548 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RapidCross™ |
| Version Model Number | A14BX035020170 |
| Company DUNS | 968903703 |
| Company Name | Covidien LP |
| 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 |
Device Dimensions
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 | 00763000111052 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2018-12-30 |
On-Brand Devices [RapidCross™]
| 00763000111359 | PTA A14BX040210170 RAPIDCROSS V04 |
| 00763000111342 | PTA A14BX040210090 RAPIDCROSS V04 |
| 00763000111335 | PTA A14BX040150170 RAPIDCROSS V04 |
| 00763000111328 | PTA A14BX040150090 RAPIDCROSS V04 |
| 00763000111311 | PTA A14BX040120170 RAPIDCROSS V04 |
| 00763000111304 | PTA A14BX040120090 RAPIDCROSS V04 |
| 00763000111298 | PTA A14BX040100170 RAPIDCROSS V04 |
| 00763000111281 | PTA A14BX040100090 RAPIDCROSS V04 |
| 00763000111274 | PTA A14BX040080170 RAPIDCROSS V04 |
| 00763000111267 | PTA A14BX040080090 RAPIDCROSS V04 |
| 00763000111250 | PTA A14BX040060170 RAPIDCROSS V04 |
| 00763000111243 | PTA A14BX040060090 RAPIDCROSS V04 |
| 00763000111236 | PTA A14BX040040170 RAPIDCROSS V04 |
| 00763000111229 | PTA A14BX040040090 RAPIDCROSS V04 |
| 00763000111212 | PTA A14BX040020170 RAPIDCROSS V04 |
| 00763000111205 | PTA A14BX040020090 RAPIDCROSS V04 |
| 00763000111199 | PTA A14BX035210170 RAPIDCROSS V04 |
| 00763000111182 | PTA A14BX035210090 RAPIDCROSS V04 |
| 00763000111175 | PTA A14BX035150170 RAPIDCROSS V04 |
| 00763000111168 | PTA A14BX035150090 RAPIDCROSS V04 |
| 00763000111151 | PTA A14BX035120170 RAPIDCROSS V04 |
| 00763000111144 | PTA A14BX035120090 RAPIDCROSS V04 |
| 00763000111137 | PTA A14BX035100170 RAPIDCROSS V04 |
| 00763000111120 | PTA A14BX035100090 RAPIDCROSS V04 |
| 00763000111113 | PTA A14BX035080170 RAPIDCROSS V04 |
| 00763000111106 | PTA A14BX035080090 RAPIDCROSS V04 |
| 00763000111090 | PTA A14BX035060170 RAPIDCROSS V04 |
| 00763000111083 | PTA A14BX035060090 RAPIDCROSS V04 |
| 00763000111076 | PTA A14BX035040170 RAPIDCROSS V04 |
| 00763000111069 | PTA A14BX035040090 RAPIDCROSS V04 |
| 00763000111052 | PTA A14BX035020170 RAPIDCROSS V04 |
| 00763000111045 | PTA A14BX035020090 RAPIDCROSS V04 |
| 00763000111038 | PTA A14BX030210170 RAPIDCROSS V04 |
| 00763000111021 | PTA A14BX030210090 RAPIDCROSS V04 |
| 00763000111014 | PTA A14BX030150170 RAPIDCROSS V04 |
| 00763000111007 | PTA A14BX030150090 RAPIDCROSS V04 |
| 00763000110994 | PTA A14BX030120170 RAPIDCROSS V04 |
| 00763000110987 | PTA A14BX030120090 RAPIDCROSS V04 |
| 00763000110970 | PTA A14BX030100170 RAPIDCROSS V04 |
| 00763000110963 | PTA A14BX030100090 RAPIDCROSS V04 |
| 00763000110956 | PTA A14BX030080170 RAPIDCROSS V04 |
| 00763000110949 | PTA A14BX030080090 RAPIDCROSS V04 |
| 00763000110932 | PTA A14BX030060170 RAPIDCROSS V04 |
| 00763000110925 | PTA A14BX030060090 RAPIDCROSS V04 |
| 00763000110918 | PTA A14BX030040170 RAPIDCROSS V04 |
| 00763000110901 | PTA A14BX030040090 RAPIDCROSS V04 |
| 00763000110895 | PTA A14BX030020170 RAPIDCROSS V04 |
| 00763000110888 | PTA A14BX030020090 RAPIDCROSS V04 |
| 00763000110871 | PTA A14BX025210170 RAPIDCROSS V04 |
| 00763000110864 | PTA A14BX025210090 RAPIDCROSS V04 |
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.