Prodigy™ Catheter PRODIGY6F
GUDID 00850032079051
6F Prodigy™ Catheter Length: 137 cm Inner Diameter: 0.071 in Outer Diameter: 0.085 in (2.13 mm)
Truvic Medical, Inc.
Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter| Primary Device ID | 00850032079051 |
| NIH Device Record Key | f824abc0-6312-4b71-890f-126caba83ecb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prodigy™ Catheter |
| Version Model Number | PRODIGY6F |
| Catalog Number | PRODIGY6F |
| Company DUNS | 104006631 |
| Company Name | Truvic Medical, 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 | 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
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Catheter Length | 137 Centimeter |
| Catheter Inner Diameter | 0.071 Inch |
| Outer Diameter | 0.085 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Length | 137 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850032079051 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K214114
FDA Product Code
| QEW | Peripheral Mechanical Thrombectomy With Aspiration |
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 | 2022-08-18 |
| Device Publish Date | 2022-08-10 |
On-Brand Devices [Prodigy™ Catheter]
| 08500320790077 | 8F Short Prodigy™ Catheter Length: 50 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2. |
| 08500320790060 | 8F Prodigy™ Catheter Length: 90 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2.80 mm) |
| 08500320790053 | 6F Prodigy™ Catheter Length: 137 cm Inner Diameter: 0.071 in Outer Diameter: 0.085 in (2.13 mm |
| 08500320790046 | 5F Prodigy™ Catheter Length: 160 cm Inner Diameter: 0.055 in Outer Diameter: 0.067 in (1.70 mm |
| 00850032079075 | 8F Short Prodigy™ Catheter Length: 50 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2. |
| 00850032079068 | 8F Prodigy™ Catheter Length: 90 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2.80 mm) |
| 00850032079051 | 6F Prodigy™ Catheter Length: 137 cm Inner Diameter: 0.071 in Outer Diameter: 0.085 in (2.13 m |
| 00850032079044 | 5F Prodigy™ Catheter Length: 160 cm Inner Diameter: 0.055 in Outer Diameter: 0.067 in (1.70 m |
| 00850032079143 | 8F Prodigy™ Catheter Length: 117 cm Inner Diameter: 2.2 mm Outer Diameter: 2.8 mm |
Trademark Results [Prodigy]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.