All'InCath 035M PTA Balloon Dilatation Catheter

FDA UDI

Class II (US FDA UDI)

by Nexstep Medical

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-80-5x80 FDA UDI
Primary DI / UDI-DI: 03701261100412 FDA UDI
510(k) Number: K191275 FDA UDI
FDA Product Code: LIT FDA UDI
KRA FDA UDI
GMDN Term: Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
870.1210 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Catheter Length — 80 Centimeter FDA UDI
Balloon Diameter — 5 Millimeter FDA UDI
Balloon Length — 80 Millimeter FDA UDI
Balloon Rated Burst Pressure — 16 Atmosphere FDA UDI
Introducer Sheath Compatibility — 6 French FDA UDI
Guidewire Compatibility — 0.035 French FDA UDI
Pressure — 1100 Pound per Square Inch FDA UDI
Balloon Nominal (Inflation) Pressure — 9 Atmosphere FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

All'InCath 035M PTA Balloon Dilatation Catheter by Nexstep Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral angioplasty balloon catheter, basic.

Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
Advocate™ — Merit Medical Systems, Inc. · Class II
Senri — KANEKA Corporation · Class IIa
Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
Pacific™ Plus — MEDTRONIC, INC. · Class II
Metacross OTW — KANEKA Corporation · Class IIa
Armada — Abbott Vascular · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Nexstep Medical

Sources (1)

FDA UDI 008ed999-c2ff-4beb-a05c-f5055220891b 37 fields · synced May 30, 2026