TriClip™ TSGC0201
GUDID 05415067047748
Steerable Guide Catheter
ST. JUDE MEDICAL, INC.
Vascular guide-catheter, single-use| Primary Device ID | 05415067047748 |
| NIH Device Record Key | 4611e760-8952-47bf-9b9e-ecaadc3d7c88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TriClip™ |
| Version Model Number | TSGC0201 |
| Catalog Number | TSGC0201 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE 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
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 8.4 Millimeter |
| Length | 80 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067047748 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P230007
FDA Product Code
| DQY | Catheter, percutaneous |
| NPS | Tricuspid valve repair device, percutaneously delivered |
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 | 2024-04-22 |
| Device Publish Date | 2024-04-12 |
On-Brand Devices [TriClip™]
| 05415067047755 | G4 Delivery System |
| 05415067047748 | Steerable Guide Catheter |
| 05415067047731 | G4 Delivery System |
| 05415067047724 | G4 Delivery System |
| 05415067047700 | G4 Delivery System |
Trademark Results [TriClip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRICLIP 88155505 5933609 Live/Registered |
Evalve, Inc. 2018-10-15 |
 TRICLIP 76422645 2795866 Dead/Cancelled |
COOK MEDICAL TECHNOLOGIES LLC 2002-06-19 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.