All'InCath 035M PTA Balloon Dilatation Catheter
FDA 510(k)FDA UDIClass II (US FDA 510(k))
Identity
- Trade Name
- All'InCath 035M PTA Balloon Dilatation Catheter FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- All'InCath 035M PTA Balloon Dilatation Catheter FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- All'InCath 035M PTA Balloon Dilatation Catheter FDA UDI
Identifiers
- Catalog Number
- AL035P-80-5x20 FDA UDI
- Primary DI / UDI-DI
- 03701261100443 FDA UDI
- 510(k) Number
- FDA Product Code
- LIT FDA 510(k)FDA UDIKRA FDA UDI
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)FDA UDI870.1210 FDA UDI
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Catheter Working Length — 80 Centimeter FDA UDIBalloon Diameter — 5 Millimeter FDA UDIBalloon Length — 20 Millimeter FDA UDIBalloon Rated Burst Pressure — 16 Atmosphere FDA UDIIntroducer Sheath Compatibility — 6 French FDA UDIGuidewire Compatibility — 0.035 French FDA UDIPressure — 1100 Pound per Square Inch FDA UDIBalloon Nominal (Inflation) Pressure — 9 Atmosphere FDA UDI
The All'InCath 035M PTA Balloon Dilatation Catheter is a catheter, angioplasty, peripheral, transluminal designed for percutaneous transluminal angioplasty (PTA). It features a semi-compliant balloon intended to dilate narrowed or obstructed blood vessels in peripheral arteries, improving blood flow.
This over-the-wire (OTW) device is single-use and sterile, compatible with 0.035-inch guidewires. It includes a three-port proximal hub for contrast injection, guidewire access, and balloon inflation/deflation. The catheter is supplied as a reusable administrative classification (LIT) and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of January 15, 2020.
Frequently asked questions
What is the primary use of the All'InCath 035M PTA Balloon Dilatation Catheter, and how does it improve patient outcomes?
The All'InCath 035M is designed specifically for percutaneous transluminal angioplasty (PTA) in peripheral arteries, where it dilates narrowed or obstructed blood vessels to restore proper blood flow. Its semi-compliant balloon gently expands the vessel lumen, reducing stenosis and improving circulation without requiring surgical intervention. This helps alleviate symptoms like claudication, ulcers, or rest pain in patients with peripheral arterial disease.
Is this catheter compatible with existing guidewire systems, and if so, what size guidewire does it require?
Yes, the All'InCath 035M is an over-the-wire (OTW) catheter, meaning it is designed to be advanced over a pre-placed guidewire. It is specifically compatible with 0.035-inch guidewires, a standard size in peripheral vascular procedures, ensuring flexibility in clinical workflows.
How is the catheter supplied, and what features does the proximal hub include for procedural convenience?
The All'InCath 035M is supplied sterile and single-use, ensuring safety and compliance with infection control protocols. Its three-port proximal hub provides three critical functions: one port for contrast injection (to visualize the vessel), another for guidewire access (to maintain wire position), and the third for balloon inflation/deflation (to control dilation pressure). This design streamlines procedures by consolidating essential functions into a single interface.
What storage or handling considerations should be noted for this catheter before and after use?
Since the All'InCath 035M is sterile and single-use, it must be stored in its original packaging until ready for use to maintain sterility. The packaging should be kept in a clean, dry environment away from direct sunlight or extreme temperatures to preserve the catheter’s integrity. After use, it should be discarded according to facility protocols for single-use medical devices, as reuse is not recommended.
How was the regulatory pathway for this device determined, and what does that mean for clinicians?
The All'InCath 035M received FDA 510(k) clearance under the Traditional pathway, meaning the manufacturer demonstrated that it is substantially equivalent to a legally marketed predicate device (a previously approved PTA catheter). For clinicians, this indicates that the device has undergone rigorous review by the FDA’s Cardiovascular (CV) Advisory Committee to ensure safety and effectiveness for its intended use in peripheral angioplasty, providing confidence in its clinical performance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NexStep Medical - All'InCath 035M*, All InCath 035M PTA Balloon Dilatation Catheter, K191275 - All'InCath 035M PTA Balloon Dilatation Catheter - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191275 | Class II | Active |
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Manufacturer
- Manufacturer
- Nexstep Medical
Sources (2)
- FDA 510(k) K191275 24 fields · synced Sep 19, 2026
- FDA UDI 0a2c9811-4211-4fa0-bfb9-b8095b416048 37 fields · synced May 27, 2026