Quick-Cross™ Capture™ 519-106
GUDID M204519106AA0
Quick-Cross™ Capture™ Guidewire Retriever
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 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 | M204519106AA0 |
| NIH Device Record Key | 19f735b4-3b76-4312-b216-8cab0a923b3f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quick-Cross™ Capture™ |
| Version Model Number | 519-106AA |
| Catalog Number | 519-106 |
| 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 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.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 | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 110 Centimeter |
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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 | 00813132020996 [Primary] |
| HIBCC | M204519106AA0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120964
FDA Product Code
| DQY | Catheter, Percutaneous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
Ethylene Oxide
[M204519106AA0]
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™ Capture™]
| M204519106AA0 | Quick-Cross™ Capture™ Guidewire Retriever |
| M2045191060 | Quick-Cross™ Capture™ Guidewire Retriever |
Trademark Results [Quick-Cross]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUICK-CROSS 78278418 2928706 Live/Registered |
The Spectranetics Corporation 2003-07-24 |
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