Stellarex™ AB35SX050120135
GUDID 00813132028961
Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
Philips Image Guided Therapy Corporation
Peripheral angioplasty balloon catheter, drug-coated| Primary Device ID | 00813132028961 |
| NIH Device Record Key | 72316c78-d317-49cb-a327-20f2f91e28a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stellarex™ |
| Version Model Number | AB35SX050120135-A |
| Catalog Number | AB35SX050120135 |
| Company DUNS | 118354223 |
| Company Name | Philips Image Guided Therapy Corporation |
| 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 | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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
Device Dimensions
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 5 Millimeter |
| Balloon Length | 120 Millimeter |
| Catheter Length | 135 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132028961 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P160049
FDA Product Code
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
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 | 2022-01-21 |
| Device Publish Date | 2022-01-13 |
On-Brand Devices [Stellarex™]
| 00813132029173 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029166 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029159 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029142 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029135 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029128 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029111 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029104 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029098 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029081 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029074 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029067 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029050 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029043 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029036 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029029 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029012 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132029005 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028992 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028985 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028978 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028961 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028954 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028947 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028930 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028923 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028916 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028909 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028893 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028886 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028879 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028862 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028855 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028848 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028831 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028817 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028800 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028794 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028787 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028770 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
| 00813132028763 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
Trademark Results [Stellarex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STELLAREX 98281976 not registered Live/Pending |
Pitcher, Charles Spencer 2023-11-22 |
 STELLAREX 85958731 4993727 Live/Registered |
Covidien LP 2013-06-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.