SilverHawk™
GUDID 00763000918927
ATHERECTOMY P4044 EXL SILVERHAWK BTK UNI
MEDTRONIC, INC.
Mechanical atherectomy system catheter, peripheral| Primary Device ID | 00763000918927 |
| NIH Device Record Key | 855d39a1-af04-406d-81ce-53c32a1ab5d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SilverHawk™ |
| Version Model Number | P4044 |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Balloon Catheter Tip Length | 6 Centimeter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| 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 *Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000918927 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170191
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 | 2024-08-19 |
| Device Publish Date | 2024-08-10 |
On-Brand Devices [SilverHawk™]
| 00643169968479 | ATHERECTOMY P4044 EXL SILVERHAWK BTK UNI |
| 00643169968462 | ATHERECTOMY P4030 SS+ SILVERHAWK BTK UNI |
| 00643169968455 | ATHERECTOMY P4028 DS SILVERHAWK BTK UNI |
| 00643169968448 | ATHERECTOMY P4056 MS-M SILVERHAWK ATK UN |
| 00643169968431 | ATHERECTOMY P4055 LX-M SILVERHAWK ATK UN |
| 00763000918927 | ATHERECTOMY P4044 EXL SILVERHAWK BTK UNI |
| 00763000918910 | ATHERECTOMY P4028 DS SILVERHAWK BTK UNI |
Trademark Results [SilverHawk]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SILVERHAWK 85281174 4214826 Live/Registered |
Globe Pipe Hanger Products Inc. 2011-03-30 |
 SILVERHAWK 76512055 2921272 Live/Registered |
COVIDIEN LP 2003-05-05 |
 SILVERHAWK 76324197 2784756 Dead/Cancelled |
NEVADA POWER COMPANY 2001-10-10 |
 SILVERHAWK 76324196 2767656 Dead/Cancelled |
NEVADA POWER COMPANY 2001-10-10 |
 SILVERHAWK 76300662 2860699 Dead/Cancelled |
NEVADA POWER COMPANY 2001-08-16 |
 SILVERHAWK 75500907 not registered Dead/Abandoned |
LUYSTER, FRANK C. 1998-06-12 |
 SILVERHAWK 75149625 2057599 Dead/Cancelled |
Pulte Home Corporation 1996-08-13 |
 SILVERHAWK 73726992 1519208 Dead/Cancelled |
PULTE HOME CORPORATION 1988-05-09 |
 SILVERHAWK 73726991 1519207 Dead/Cancelled |
PULTE HOME CORPORATION 1988-05-09 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.