Finesse Injectable PTA Balloon Dilatation Catheter OTW 014
Finesse Injectable is an over-the-wire balloon catheter for peripheral angioplasty. It combines a semi-compliant balloon and low-profile tip with a separate fluid-injection pathway,…
Finesse Injectable is an over-the-wire balloon catheter for peripheral angioplasty. It combines a semi-compliant balloon and low-profile tip with a separate fluid-injection pathway, allowing treatment and fluid delivery through the same catheter.
One lumen inflates and deflates the balloon. The other accommodates a 0.014-inch guidewire and delivers fluid through exit holes positioned just before the balloon. Separate proximal ports connect to these two pathways.
Listed Item
PTA Cath 2.0-100-150-8
Positioning and Dimensions
Two radiopaque bands mark the balloon’s working segment, and another marks the injection-hole region relative to a guiding sheath. A hydrophilic coating covers the distal coaxial shaft. The catheter has a 150 cm working length, with several balloon lengths for peripheral arteries and obstructed native or synthetic dialysis fistulae.
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Kossel Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Summa Therapeutics, LLC, United States |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K230263 |
| Record published | 2023-08-01 |
| Record revised | 2024-08-14 (version 3) |
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 |
| Sizes | Balloon diameter 2 to 4 mm; balloon length 20 to 225 mm; catheter working length 150 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FS201001508 | Balloon Diameter 2.0 mm | In distribution |
| FS351001508 | Balloon Diameter 3.5 mm | In distribution |
| FS402251508 | Balloon Diameter 4.0 mm | In distribution |
| FS350201508 | Balloon Diameter 3.5 mm | In distribution |
| FS250201508 | Balloon Diameter 2.5 mm | In distribution |
| FS202251508 | Balloon Diameter 2.0 mm | In distribution |
| FS200401508 | Balloon Diameter 2.0 mm | In distribution |
| FS350601508 | Balloon Diameter 3.5 mm | In distribution |
| FS400401508 | Balloon Diameter 4.0 mm | In distribution |
| FS250401508 | Balloon Diameter 2.5 mm | In distribution |
| FS352251508 | Balloon Diameter 3.5 mm | In distribution |
| FS302251508 | Balloon Diameter 3.0 mm | In distribution |
| FS400201508 | Balloon Diameter 4.0 mm | In distribution |
| FS200601508 | Balloon Diameter 2.0 mm | In distribution |
| FS300201508 | Balloon Diameter 3.0 mm | In distribution |
| FS300401508 | Balloon Diameter 3.0 mm | In distribution |
| FS300601508 | Balloon Diameter 3.0 mm | In distribution |
| FS251001508 | Balloon Diameter 2.5 mm | In distribution |
| FS400601508 | Balloon Diameter 4.0 mm | In distribution |
| FS200201508 | Balloon Diameter 2.0 mm | In distribution |
| FS250601508 | Balloon Diameter 2.5 mm | In distribution |
| FS301001508 | Balloon Diameter 3.0 mm | In distribution |
| FS401001508 | Balloon Diameter 4.0 mm | In distribution |
| FS350401508 | Balloon Diameter 3.5 mm | In distribution |
| FS252251508 | Balloon Diameter 2.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Parafleet SC 018 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 1,460 |
| Jade Plus PTA Balloon Dilatation Catheter / Jade Plus 18 OTW | OrbusNeich Medical (Shenzhen) Co., Ltd. | 832 |
| Jade PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 667 |
| Parafleet SC 014 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 572 |
| Minerva PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 504 |
| Advocate | Arravasc, Ltd. | 441 |
| Ultraverse® 035 PTA Dilatation Catheter | Bard Peripheral Vascular, Inc. | 361 |
| Polux PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 359 |
| Advance | Cook Incorporated | 355 |
| Pacific™ Plus | Medtronic, Inc. | 347 |
| EverCross™ | ev3, Inc. | 316 |
| Achilles NC PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 297 |
Showing 12 of 167. All products under Catheter, Angioplasty, Peripheral, Transluminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241740 | 2024-07-16 |
| K230263 | 2023-05-26 |
| K150452 | 2015-08-13 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Summa Therapeutics, LLC | 510(k) number | 2025-07-21 | Class II | Process control | Potential for the balloon in the device to not meet burst specifications. | 22 units |
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.