AXS Offset DC050150A
GUDID 07613327361155
Delivery Assist Catheter
Stryker Corporation
Vascular guide-catheter, single-use| Primary Device ID | 07613327361155 |
| NIH Device Record Key | 64ed94d2-9976-4c71-a9cf-12282d80336e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AXS Offset |
| Version Model Number | M003DC050150A0 |
| Catalog Number | DC050150A |
| Company DUNS | 042405446 |
| Company Name | Stryker 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
Device Dimensions
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327361155 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163259
FDA Product Code
| DQY | CATHETER, PERCUTANEOUS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-23 |
| Device Publish Date | 2017-12-06 |
Devices Manufactured by Stryker Corporation
| 07613327661989 - KNOTILUS+ | 2025-06-24 2.9X15.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE |
| 07613327661996 - KNOTILUS+ | 2025-06-24 2.4X8.9MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE |
| 07613327662009 - KNOTILUS+ | 2025-06-24 2.4X11.3MM KNOTILUS+ ANCHOR - BIOCOMPOSITE |
| 07613327662016 - KNOTILUS+ | 2025-06-24 2.9X12.5MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE |
| 07613327662023 - KNOTILUS+ | 2025-06-24 2.9X12.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE |
| 07613327662030 - ALPHAVENT | 2025-06-24 ALPHAVENT KNOTLESS SP, 4.75MM, BIOCOMPOSITE ANCHOR |
| 07613327662047 - ALPHAVENT | 2025-06-24 ALPHAVENT KNOTLESS SP, 5.5MM, BIOCOMPOSITE ANCHOR |
| 07613327662054 - ALPHAVENT | 2025-06-24 ALPHAVENT KNOTLESS SP, 6.5MM, BIOCOMPOSITE ANCHOR |
Trademark Results [AXS Offset]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AXS OFFSET 87021393 5788129 Live/Registered |
Stryker Corporation 2016-05-02 |
AXS OFFSET 87021393 5788129 Live/Registered |
Stryker European Holdings I, LLC 2016-05-02 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.