Arrow

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: ARROW FDA UDI
Generic Name: Temporary cardiac pacing balloon catheter FDA UDI
Device Name: Bipolar Balloon Double Wedge Pressure Pacing Catheter FDA UDI
Model / Reference: IPN919938 FDA UDI
Description: Bipolar Balloon Double Wedge Pressure Pacing Catheter FDA UDI

Identifiers

Catalog Number: AI-17210-S FDA UDI
Primary DI / UDI-DI: 10801902198386 FDA UDI
510(k) Number: K960479 FDA UDI
FDA Product Code: LDF FDA UDI
GMDN Term: Temporary cardiac pacing balloon catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3680 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

Yes

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 — 7 French FDA UDI
Length — 110 Centimeter FDA UDI

Category: Temporary cardiac pacing balloon catheter

Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Temporary cardiac pacing balloon catheter.

Pacel™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION · Class II
Tempo Temporary Pacing Lead — Biotrace Medical, Inc. · Class II
SWAN-GANZ — Edwards Lifesciences LLC · Class II
Bipolar 5FR 110cm Modified-J Shrouded Pins — ALPHA MEDICAL INSTRUMENTS LLC · Class II
Pacel™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION · Class II
SWAN-GANZ — Edwards Lifesciences LLC · Class II
SWAN-GANZ — Edwards Lifesciences LLC · Class II
Pacel™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION · Class II

Cleared under the same submission

K960479 also covers:

ARROW — TELEFLEX INCORPORATED
ARROW — TELEFLEX INCORPORATED

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: Teleflex Incorporated

Sources (1)

FDA UDI 1f9bc7d5-2765-4f2f-9daa-998564e6b2eb 38 fields · synced May 30, 2026