Arrow

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: ARROW FDA UDI
Generic Name: Intra-aortic balloon pump FDA UDI
Device Name: AUTOCAT2 WAVE FRENCH FDA UDI
Model / Reference: IPN000323 FDA UDI
Description: AUTOCAT2 WAVE FRENCH FDA UDI

Identifiers

Catalog Number: IAP-0500F FDA UDI
Primary DI / UDI-DI: 30801902092183 FDA UDI
510(k) Number: K060309 FDA UDI
FDA Product Code: DSP FDA UDI
GMDN Term: Intra-aortic balloon pump FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3535 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Intra-aortic balloon pump

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

Similar devices

Also classified as Intra-aortic balloon pump.

CS300 Intra-Aortic Balloon Pump, French, 220V — Datascope Corp. · Class II
CS300 Accessory Kit, Japanese 110 V — Datascope Corp. · Class II
CS300 Intra-Aortic Balloon Pump, French, 110V — Datascope Corp. · Class II
CS300 Intra-Aortic Balloon Pump, Refurbished, PORTUGUESE, NON-UTS, DOM — Datascope Corp. · Class II
CS300 Accessory Kit, Portuguese, 110 V — Datascope Corp. · Class II
CARDIOSAVE HYBRID TYPE K PLUG — Datascope Corp. · Class II
CS300 Intra-Aortic Balloon Pump, German, 220V — Datascope Corp. · Class II
ASSY CRM SWEDISH — Datascope Corp. · Class II

Cleared under the same submission

K060309 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

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Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI 3ae086b6-9707-4417-89b3-f1da9b634869 36 fields · synced Jun 8, 2026