Prodigy™ Catheter PRODIGY8F
GUDID 00850032079068
8F Prodigy™ Catheter Length: 90 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2.80 mm)
Truvic Medical, Inc.
Thrombectomy suction catheter| Primary Device ID | 00850032079068 |
| NIH Device Record Key | d17720a5-0d76-4ce1-a2f3-cbd22b245f1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prodigy™ Catheter |
| Version Model Number | PRODIGY8F |
| Catalog Number | PRODIGY8F |
| 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 | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 90 Centimeter |
| Catheter Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
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 |
| 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 | 00850032079068 [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]
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.