All’InCath 035m PTA Balloon Dilatation Catheter
All'InCath 035M combines a peripheral angioplasty balloon with a separate contrast-injection lumen. The over-the-wire catheter accepts a 0.035 inch guidewire. Its three-port hub has…
All’InCath 035M combines a peripheral angioplasty balloon with a separate contrast-injection lumen. The over-the-wire catheter accepts a 0.035 inch guidewire.
Its three-port hub has separate channels for guidewire access, balloon inflation and contrast delivery. Contrast exits through three holes proximal to the balloon, identified by a radiopaque marker.
Positioning and Use
Two additional radiopaque bands identify the balloon’s dilating section, and the tip is soft radiopaque tubing. The sterile, single-use catheter supports peripheral angioplasty and angiographic visualization, including specified dialysis-fistula applications. It is not intended for coronary use.
5manufacturers in China registered for this device type
48catalogue numbers in this listing
1510(k) clearance
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 | Nexstep Medical, France |
|---|---|
| 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) | K191275 |
| Record published | 2025-06-12 |
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 4 to 10 mm; balloon rated burst pressure 14 to 18 Atmosphere; introducer sheath compatibility 6 to 7 Fr; guidewire compatibility 0.035 Fr; balloon nominal (inflation) pressure 8 to 12 Atmosphere; balloon length 20 to 80 mm; pressure 1100 psi; catheter working length 80 to 120 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 120 mm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Length 80 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 120 mm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 80 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 120 mm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 120 cm | In distribution |
| 1 | Catheter Working Length 120 mm | In distribution |
| 1 | Catheter Working Length 80 cm | 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 |
|---|---|
| K191275 | 2020-01-15 |
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.