Phoenix Atherectomy P18149K
GUDID 00845225003555
Phoenix Atherectomy System, 1.8mm x 149cm, 5F
Volcano Atheromed, Inc.
Mechanical atherectomy system catheter, peripheral| Primary Device ID | 00845225003555 |
| NIH Device Record Key | 21288663-8686-4c5b-a4f9-0358a78856ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Phoenix Atherectomy |
| Version Model Number | P18149K |
| Catalog Number | P18149K |
| Company DUNS | 788341084 |
| Company Name | Volcano Atheromed, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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
Device Dimensions
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 149 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845225003555 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143328
FDA Product Code
| MCW | Catheter, Peripheral, Atherectomy |
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 | 2024-07-16 |
| Device Publish Date | 2024-07-08 |
On-Brand Devices [Phoenix Atherectomy]
| 00845225003593 | Phoenix Atherectomy Deflecting System, 2.4mm x 130cm, 7F |
| 00845225003586 | Phoenix Atherectomy Deflecting System, 2.2mm x 130cm, 6F |
| 00845225003579 | Phoenix Atherectomy System, 2.2mm x 149cm, 6F |
| 00845225003562 | Phoenix Atherectomy System, 2.2mm x 130cm, 6F |
| 00845225003555 | Phoenix Atherectomy System, 1.8mm x 149cm, 5F |
| 00845225003548 | Phoenix Atherectomy System, 1.8mm x 130cm, 5F |
| 00845225003531 | Phoenix Atherectomy System, 1.5mm x 149cm, 4F |
| 00845225003524 | Phoenix Atherectomy Deflecting Catheter, 2.4mm x 130cm, 7F |
| 00845225003517 | Phoenix Atherectomy Deflecting Catheter, 2.2mm x 130cm, 6F |
| 00845225003500 | Phoenix Atherectomy Catheter, 2.2mm x 149cm, 6F |
| 00845225003494 | Phoenix Atherectomy Catheter, 2.2mm x 130cm, 6F |
| 00845225003487 | Phoenix Atherectomy Catheter, 1.8mm x 149cm, 5F |
| 00845225003470 | Phoenix Atherectomy Catheter, 1.8mm x 130cm, 5F |
| 00845225003463 | Phoenix Atherectomy Catheter, 1.5mm x 149cm, 4F |
Trademark Results [Phoenix Atherectomy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PHOENIX ATHERECTOMY 85975940 not registered Dead/Abandoned |
Atheromed, Inc. 2010-10-11 |
 PHOENIX ATHERECTOMY 85149326 not registered Dead/Abandoned |
Atheromed, Inc. 2010-10-11 |
 PHOENIX ATHERECTOMY 77383816 3974870 Live/Registered |
VOLCANO ATHEROMED, INC. 2008-01-30 |
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