Serranator
GUDID 00852495008487
The Serranator® PTA Serration Balloon Catheter is an Over-The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semi-compliant balloon with two embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
CAGENT VASCULAR, LLC
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00852495008487 |
| NIH Device Record Key | 5a64cc1c-ad4e-46ef-8d36-defb1e99eb04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Serranator |
| Version Model Number | FGS-0682-20120 |
| Company DUNS | 009984330 |
| Company Name | CAGENT VASCULAR, LLC |
| 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 | true |
| 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 | 9258186875 |
| pjohansson@cagentvascular.com | |
| Phone | 9258186875 |
| pjohansson@cagentvascular.com | |
| Phone | 9258186875 |
| pjohansson@cagentvascular.com | |
| Phone | 9258186875 |
| pjohansson@cagentvascular.com | |
| Phone | 9258186875 |
| pjohansson@cagentvascular.com | |
| Phone | 9258186875 |
| pjohansson@cagentvascular.com |
Device Dimensions
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 120 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 120 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 120 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 120 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 120 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 120 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852495008487 [Primary] |
FDA Product Code
| PNO | Catheter, Percutaneous, Cutting/Scoring |
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 | 2024-12-23 |
| Device Publish Date | 2024-12-13 |
On-Brand Devices [Serranator]
| 00852495008005 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008173 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008166 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008159 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008142 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008135 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008128 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008111 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008104 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008098 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008081 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008067 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008050 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008036 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008029 | The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat |
| 00852495008500 | The Serranator® PTA Serration Balloon Catheter is an Over-The-Wire (OTW) balloon dilatation cat |
| 00852495008494 | The Serranator® PTA Serration Balloon Catheter is an Over-The-Wire (OTW) balloon dilatation cat |
| 00852495008487 | The Serranator® PTA Serration Balloon Catheter is an Over-The-Wire (OTW) balloon dilatation cat |
Trademark Results [Serranator]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SERRANATOR 87951314 not registered Live/Pending |
Cagent Vascular, LLC 2018-06-06 |
 SERRANATOR 87145836 5170895 Live/Registered |
Cagent Vascular, LLC 2016-08-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.