Serranator
- Primary DI
- 00852495008135
- Brand
- Serranator
- Company
- CAGENT VASCULAR, LLC
- Model
- FGS-0346-30080
- Device description
- 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. The Serranator® has a nylon semi- compliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to create linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
- Published
- 2024-11-13
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring | Cardiovascular | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00852495008135 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00852495008135 | 00852495008135 | 852495008135 | 0852495008135 |
GMDN Terms#
| Term | Definition |
|---|---|
| Peripheral angioplasty balloon catheter, basic | A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Balloon Diameter | 3 | Millimeter |
| Balloon Length | 80 | Millimeter |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 9258186875 | pjohansson@cagentvascular.com |
Regulatory Flags#
- DUNS number
- 009984330
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00852495008487 | Serranator | FGS-0682-20120 | 2024-12-13 | |
| 00852495008494 | Serranator | FGS-0682-20040 | 2024-12-13 | |
| 00852495008500 | Serranator | FGS-0682-20020 | 2024-12-13 | |
| 00852495008029 | Serranator | FGS-0492-40120 | 2024-11-13 | |
| 00852495008036 | Serranator | FGS-0492-50040 | 2024-11-13 | |
| 00852495008050 | Serranator | FGS-0492-50120 | 2024-11-13 | |
| 00852495008067 | Serranator | FGS-0492-60040 | 2024-11-13 | |
| 00852495008081 | Serranator | FGS-0492-60120 | 2024-11-13 | |
| 00852495008098 | Serranator | FGS-0346-25040 | 2024-11-13 | |
| 00852495008104 | Serranator | FGS-0346-25080 | 2024-11-13 | |
| 00852495008111 | Serranator | FGS-0346-25120 | 2024-11-13 | |
| 00852495008128 | Serranator | FGS-0346-30040 | 2024-11-13 | |
| 00852495008142 | Serranator | FGS-0346-30120 | 2024-11-13 | |
| 00852495008159 | Serranator | FGS-0346-35040 | 2024-11-13 | |
| 00852495008166 | Serranator | FGS-0346-35080 | 2024-11-13 | |
| 00852495008173 | Serranator | FGS-0346-35120 | 2024-11-13 | |
| 00852495008005 | Serranator | FGS-0492-40040 | 2024-11-12 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06923533801057 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-05-15 |
| B090XC2201450 | XO Constrain | ZIEN MEDICAL TECHNOLOGIES, INC. | PNO | 2026-02-03 |
| B090XC2201451 | XO Constrain | ZIEN MEDICAL TECHNOLOGIES, INC. | PNO | 2026-02-03 |
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