Quick-Cross™Select 518-085
GUDID 20813132020549
Quick-Cross™Select Support Catheter
Spectranetics Corporation
Vascular guide-catheter, single-use| Primary Device ID | 20813132020549 |
| NIH Device Record Key | 032e8126-eefc-4401-91ad-211aea048fab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quick-Cross™Select |
| Version Model Number | 518-085AA |
| Catalog Number | 518-085 |
| 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 | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com |
Device Dimensions
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132020545 [Primary] |
| GS1 | 20813132020549 [Package] Contains: 00813132020545 Package: Box [5 Units] In Commercial Distribution |
| HIBCC | M204518085AA0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092396
FDA Product Code
| DQY | Catheter, Percutaneous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
[20813132020549]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-23 |
| Device Publish Date | 2015-02-06 |
On-Brand Devices [Quick-Cross™Select]
| M204518093AB0 | Quick-Cross™Select Support Catheter |
| M204518091AB0 | Quick-Cross™Select Support Catheter |
| M204518089AB0 | Quick-Cross™Select Support Catheter |
| M204518087AB0 | Quick-Cross™Select Support Catheter |
| M204518085AB0 | Quick-Cross™Select Support Catheter |
| M204518083AB0 | Quick-Cross™Select Support Catheter |
| M204518081AB0 | Quick-Cross™Select Support Catheter |
| M204518079AB0 | Quick-Cross™Select Support Catheter |
| M204518077AB0 | Quick-Cross™Select Support Catheter |
| 20813132020624 | Quick-Cross™Select Support Catheter |
| 20813132020600 | Quick-Cross™Select Support Catheter |
| 20813132020587 | Quick-Cross™Select Support Catheter |
| 20813132020563 | Quick-Cross™Select Support Catheter |
| 20813132020549 | Quick-Cross™Select Support Catheter |
| 20813132020525 | Quick-Cross™Select Support Catheter |
| 20813132020501 | Quick-Cross™Select Support Catheter |
| 20813132020488 | Quick-Cross™Select Support Catheter |
| 20813132020464 | Quick-Cross™Select Support Catheter |
| M2045180931 | Quick-Cross™Select Support Catheter |
| M2045180911 | Quick-Cross™Select Support Catheter |
| M2045180891 | Quick-Cross™Select Support Catheter |
| M2045180871 | Quick-Cross™Select Support Catheter |
| M2045180851 | Quick-Cross™Select Support Catheter |
| M2045180831 | Quick-Cross™Select Support Catheter |
| M2045180811 | Quick-Cross™Select Support Catheter |
| M2045180791 | Quick-Cross™Select Support Catheter |
| M2045180771 | Quick-Cross™Select Support Catheter |
Trademark Results [Quick-Cross]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUICK-CROSS 78278418 2928706 Live/Registered |
The Spectranetics Corporation 2003-07-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.