Turbo Elite™ 423-135-01
GUDID M204423135010
Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
Atherectomy laser system beam guide-catheter, peripheral| Primary Device ID | M204423135010 |
| NIH Device Record Key | f1682550-f861-4aab-95e9-f42da0a41fa7 |
| Commercial Distribution Discontinuation | 2019-02-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Turbo Elite™ |
| Version Model Number | 423-135-01 |
| Catalog Number | 423-135-01 |
| Company DUNS | 151047370 |
| Company Name | Spectranetics 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 | 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 | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com |
Device Dimensions
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M204423135010 [Primary] |
FDA Product Code
| MCW | Catheter, Peripheral, Atherectomy |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
[M204423135010]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-10-26 |
| Device Publish Date | 2014-08-27 |
On-Brand Devices [Turbo Elite™]
| 00813132024819 | Turbo-Elite™ Laser Atherectomy Catheter |
| 00813132024796 | Turbo-Elite™ Laser Atherectomy Catheter |
| 00813132024789 | Turbo-Elite™ Laser Atherectomy Catheter |
| 00813132024772 | Turbo-Elite™ Laser Atherectomy Catheter |
| 00813132024765 | Turbo-Elite™ Laser Atherectomy Catheter |
| 00813132024758 | Turbo-Elite™ Laser Atherectomy Catheter |
| 00813132024741 | Turbo-Elite™ Laser Atherectomy Catheter |
| 00813132024734 | Turbo-Elite™ Laser Atherectomy Catheter |
| 00813132024727 | Turbo-Elite™ Laser Atherectomy Catheter |
| 00813132024710 | Turbo-Elite™ Laser Atherectomy Catheter |
| 00813132024703 | Turbo-Elite™ Laser Atherectomy Catheter |
| 00813132024697 | Turbo-Elite™ Laser Atherectomy Catheter |
| 00813132020217 | Turbo-Elite™ Laser Atherectomy Catheter |
| M20442313501AA0 | Turbo-Elite™ Laser Atherectomy Catheter |
| M204425135010 | Turbo-Elite™ Laser Atherectomy Catheter |
| M204423135010 | Turbo-Elite™ Laser Atherectomy Catheter |
Trademark Results [Turbo Elite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TURBO ELITE 78923700 3367148 Live/Registered |
The Spectranetics Corporation 2006-07-06 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.