Arctic Front Advance™
GUDID 00763000431501
CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
MEDTRONIC, INC.
Cardiac cryosurgical system catheter| Primary Device ID | 00763000431501 |
| NIH Device Record Key | ee956739-ca14-4da0-84b7-f1a14fdc99de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arctic Front Advance™ |
| Version Model Number | 2AF284 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| 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 | false |
| 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)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
| Catheter Working Length | 95 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10.5 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000431501 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P100010
FDA Product Code
| OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
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 | 2021-11-22 |
| Device Publish Date | 2021-11-13 |
On-Brand Devices [Arctic Front Advance™]
| 00643169939318 | CATHETER 2AF284 ARCTIC FRONT ADV US 28MM |
| 00643169939271 | CATHETER 2AF234 ARCTIC FRONT ADV US 23MM |
| 00643169753693 | CATHETER 2AF284 ARCTIC FRONT ADV US 28MM |
| 00643169753686 | CATHETER 2AF234 ARCTIC FRONT ADV US 23MM |
| 00643169504783 | CATHETER 2AF284 ARCTIC FRONT ADV US 28MM |
| 00643169345614 | CATHETER 2AF284 AFA US 28MM |
| 00643169345591 | CATHETER 2AF234 AFA US 23MM |
| 00643169976382 | CATHETER 2AF284 ARCTIC FRONT ADV US 28MM |
| 00643169976368 | CATHETER 2AF234 ARCTIC FRONT ADV US 23MM |
| 00643169878365 | CATHETER 2AF284 ARCTIC FRONT ADV US 28MM |
| 00643169878327 | CATHETER 2AF234 ARCTIC FRONT ADV US 23MM |
| 00763000341480 | CATH 2AF284 ARCTIC FRONT ADV US 28MM MVC |
| 00763000341473 | CATH 2AF234 ARCTIC FRONT ADV US 23MM MVC |
| 00763000431501 | CATHETER 2AF284 ARCTIC FRONT ADV US 28MM |
| 00763000431488 | CATHETER 2AF234 ARCTIC FRONT ADV US 23MM |
| 00763000431532 | CATH 2AF284 ARCTIC FRONT ADV US 28MM MVC |
| 00763000431518 | CATH 2AF234 ARCTIC FRONT ADV US 23MM MVC |
Trademark Results [Arctic Front Advance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARCTIC FRONT ADVANCE 85476235 4388809 Live/Registered |
Medtronic CryoCath LP 2011-11-18 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.