Ultra IABP Catheter Kit

FDA UDI

Class II (US FDA UDI)

by Insightra Medical, Inc.

Identity

Trade Name: Ultra IABP Catheter Kit FDA UDI
Generic Name: Intra-aortic balloon catheter FDA UDI
Device Name: The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This condition occurs in patients post acute myocardial infarction, or with reduced cardiac output post open-heart surgery. FDA UDI
Model / Reference: IMU7F-30 FDA UDI
Description: The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This condition occurs in patients post acute myocardial infarction, or with reduced cardiac output post open-heart surgery. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850012832485 FDA UDI
510(k) Number: K082746 FDA UDI
FDA Product Code: DSP FDA UDI
GMDN Term: Intra-aortic balloon catheter 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

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 — 7 French FDA UDI
Total Volume — 30 Milliliter FDA UDI

Category: Intra-aortic balloon catheter

Ultra IABP Catheter Kit by Insightra Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Intra-aortic balloon catheter.

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TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES — Datascope Corp. · Class II
ARROW — TELEFLEX INCORPORATED · Class II
ARROW — TELEFLEX INCORPORATED · Class II
ARROW — TELEFLEX INCORPORATED · Class II
Linear 7.5Fr. 25cc IAB — Datascope Corp. · Class II

Cleared under the same submission

K082746 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: Insightra Medical, Inc.

Sources (1)

FDA UDI b8ac6e10-5f7a-46d2-a103-d7f14cf7c0a2 36 fields · synced May 31, 2026