RapidCross A14BX035080170
GUDID 00821684050996
PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00821684050996 |
| NIH Device Record Key | b6f8e4b2-8a53-4b4e-866b-290f444946cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RapidCross |
| Version Model Number | A14BX035080170 |
| Catalog Number | A14BX035080170 |
| 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 | 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 | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Outer Diameter | 3.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 80 Millimeter |
| Outer Diameter | 3.5 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684050996 [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 | 4 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2015-10-09 |
On-Brand Devices [RapidCross]
| 00821684051115 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684051108 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684051092 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684051085 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684051078 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684051061 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684051054 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684051047 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684051030 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684051023 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684051016 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684051009 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050996 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050989 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050972 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050965 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050958 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050941 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050934 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050927 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050910 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050903 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050897 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050880 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050873 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050866 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050859 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050842 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050835 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050828 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050811 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050804 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050798 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050781 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050774 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050767 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050750 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050743 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050736 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050729 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050712 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050705 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050699 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050682 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050675 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050668 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050651 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050644 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050637 | PTA Rapid Exchange Balloon Dilatation Catheter |
| 00821684050620 | PTA Rapid Exchange Balloon Dilatation Catheter |
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.