Serranator
The Serranator® PTA Serration Balloon Catheter is an Over-The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral…
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.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Cagent Vascular, United States |
|---|---|
| FDA product code | PNO |
| Device type | Catheter, Percutaneous, Cutting/Scoring |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2024-11-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Balloon diameter 2 to 6 mm; balloon length 20 to 120 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FGS-0346-25040 | Balloon Diameter 2.5 mm | In distribution |
| FGS-0492-50120 | Balloon Diameter 5 mm | In distribution |
| FGS-0682-20120 | Balloon Diameter 2.0 mm | In distribution |
| FGS-0346-35120 | Balloon Diameter 3.5 mm | In distribution |
| FGS-0346-35040 | Balloon Diameter 3.5 mm | In distribution |
| FGS-0346-30040 | Balloon Diameter 3 mm | In distribution |
| FGS-0346-30120 | Balloon Diameter 3 mm | In distribution |
| FGS-0492-60120 | Balloon Diameter 6 mm | In distribution |
| FGS-0346-30080 | Balloon Diameter 3 mm | In distribution |
| FGS-0492-60040 | Balloon Diameter 6 mm | In distribution |
| FGS-0492-40040 | Balloon Diameter 4.0 mm | In distribution |
| FGS-0346-35080 | Balloon Diameter 3.5 mm | In distribution |
| FGS-0346-25120 | Balloon Diameter 2.5 mm | In distribution |
| FGS-0492-40120 | Balloon Diameter 4.0 mm | In distribution |
| FGS-0682-20020 | Balloon Diameter 2.0 mm | In distribution |
| FGS-0492-50040 | Balloon Diameter 5 mm | In distribution |
| FGS-0682-20040 | Balloon Diameter 2.0 mm | In distribution |
| FGS-0346-25080 | Balloon Diameter 2.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 168 |
| PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | 120 |
| VascuTrak® | Bard Peripheral Vascular, Inc. | 109 |
| Ultrascore | Bard Peripheral Vascular, Inc. | 103 |
| Scoreflex PTA Scoring Balloon Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 58 |
| AngioSculpt® | Spectranetics Corp. | 51 |
| Aperta NSE™ PTA Balloon Dilatation Catheter | Goodman Co., Ltd. | 38 |
| AngioSculpt OTW PTA Scoring Balloon Catheter | The Spectranetics Corp. | 25 |
| AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating | The Spectranetics Corp. | 13 |
| Advance Enforcer | Cook Incorporated | 12 |
| 2cm Peripheral Cutting Balloon® | Boston Scientific Corporation | 12 |
| Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | 11 |
Showing 12 of 16. All products under Catheter, Percutaneous, Cutting/Scoring
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220704 | 2022-05-04 |
| K213728 | 2021-12-15 |
| K203437 | 2020-12-22 |
| K193181 | 2020-04-15 |
| K163380 | 2017-02-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.