RapidCross

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: RapidCross FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name: PTA Rapid Exchange Balloon Dilatation Catheter FDA UDI
Model / Reference: A14BX030120090 FDA UDI
Description: PTA Rapid Exchange Balloon Dilatation Catheter FDA UDI

Identifiers

Primary DI / UDI-DI: 00821684050538 FDA UDI
510(k) Number: K130911 FDA UDI
FDA Product Code: LIT FDA UDI
GMDN Term: Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 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 Gauge — 4 French FDA UDI
Outer Diameter — 3 Millimeter FDA UDI
Length — 120 Millimeter FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

RapidCross by Covidien LP — 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

K130911 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Covidien LP

Sources (1)

FDA UDI c39388aa-4fee-4af3-bcb8-1827659493b2 37 fields · synced May 30, 2026