Turbo-Booster™ 518-063
GUDID M2045180631
Turbo-Booster™ Laser Guide Catheter
Spectranetics Corporation
Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use| Primary Device ID | M2045180631 |
| NIH Device Record Key | 0f9aba78-96ce-4dec-a0ee-808e4ce3ed6c |
| Commercial Distribution Discontinuation | 2019-02-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Turbo-Booster™ |
| Version Model Number | 518-063 |
| Catalog Number | 518-063 |
| 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 | |
| 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 | |
| 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
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
| Lumen/Inner Diameter | 0.082 Inch |
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 |
| 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 |
| 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 | M2045180630 [Primary] |
| HIBCC | M2045180631 [Package] Contains: M2045180630 Package: Box [3 Units] Discontinued: 2019-02-06 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071226
FDA Product Code
| PDU | Catheter For Crossing Total Occlusions |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M2045180631]
Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
[M2045180631]
Ethylene Oxide
[M2045180631]
Ethylene Oxide
[M2045180631]
Ethylene Oxide
[M2045180631]
Ethylene Oxide
[M2045180631]
Ethylene Oxide
[M2045180631]
Ethylene Oxide
[M2045180631]
Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2020-07-23 |
| Device Publish Date | 2014-09-15 |
On-Brand Devices [Turbo-Booster™]
| 20813132020280 | Turbo-Booster™ Laser Guide Catheter |
| 20813132020273 | Turbo-Booster™ Laser Guide Catheter |
| M2045180631 | Turbo-Booster™ Laser Guide Catheter |
| M2045180431 | Turbo-Booster™ Laser Guide Catheter |
Trademark Results [Turbo-Booster]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TURBO-BOOSTER 86372379 4712538 Live/Registered |
The Spectranetics Corporation 2014-08-20 |
 TURBO-BOOSTER 78856812 3354066 Dead/Cancelled |
The Spectranetics Corporation 2006-04-07 |
 TURBO-BOOSTER 73288937 1183688 Dead/Cancelled |
Maremont Corporation 1980-12-08 |
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