Who else makes this device?

Name: Ultra Iabp Catheter Kit
Brand: Ultra Iabp Catheter Kit

Cardiovascular › ProstheticSystem, Balloon, Intra-Aortic And Control

Ultra Iabp Catheter Kit

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…

Registry build 21.09.26

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.

1manufacturer

3catalogue numbers in this listing

1510(k) clearance

1recall

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DSP
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77

Record

Regulatory record for Ultra Iabp Catheter Kit
Listed by	Insightra Medical, Inc., United States
FDA product code	DSP
Device type	System, Balloon, Intra-Aortic And Control
Device class	Class 2
Regulation	21 CFR 870.3535
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K082746
Record published	2015-03-17
Record revised	2020-07-20 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Shipper box implant of 5, shipper box of 5, pack of 5
Sizes	Catheter gauge 7 Fr; total volume 30 to 40 ml

Catalogue Numbers

Catalogue numbers for Ultra Iabp Catheter Kit
Catalogue number	Size	Status
IMU7F-30	Catheter Gauge 7 Fr	In distribution
IMU7F-40	Total Volume 40 ml	In distribution
IMU7F-35	Total Volume 35 ml	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Arrow	Teleflex Medical LLC	224
Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB	Datascope Corp	10
CS300 Intra-Aortic Balloon Pump, Refurbished, English,non-Uts,dom	Datascope Corp	4
CS100 Intra-Aortic Balloon Pump, Refurbished, English,uts,dom	Datascope Corp	3
Advance Dental Products	THE Atlanta Dental Supply Company	3
CS300 Intra-Aortic Balloon Pump, Refurbished, Spanish,uts,intl	Datascope Corp	3
Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the Sensation Plus 7	Datascope Corp	2
CS100 Intra-Aortic Balloon Pump, Refurbished, Portuguese,non-Uts,intl	Datascope Corp	2
CS300 Intra-Aortic Balloon Pump, Refurbished, FRENCH,NON-UTS,110V	Datascope Corp	2
Yamato Plus-R 30cc IAB With Accessories AND Retraction KIT	Datascope Corp	2
CS100 Intra-Aortic Balloon Pump, Refurbished, Spanish,non-Uts,intl	Datascope Corp	2
CS300 Intra-Aortic Balloon Pump, Refurbished, Portuguese,non-Uts,intl	Datascope Corp	2

Showing 12 of 268. All products under System, Balloon, Intra-Aortic And Control

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K082746	2009-01-12

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Ultra Iabp Catheter Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Insightra Medical, Inc.	510(k) number	2025-07-19	Class II	No Marketing Application	Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training.	24227 units	2026-03-18

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.