ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20— 510(k) K082746

Name: FDA 510(k) clearance K082746
Creator: U.S. Food and Drug Administration
Published: 2009-01-12

Substantially Equivalent

Insightra Medical, Inc.

FDA 510(k) clearance K082746 for ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20, Substantially Equivalent on 2009-01-12. Applicant: Insightra Medical, Inc.. Device class: 2.

Clearance details

Applicant: Insightra Medical, Inc.
Product code: Code DSP
Device class: Class 2
Regulation: 21 CFR 870.3535
Advisory panel: Cardiovascular
Date received: 2008-09-19
Decision date: 2009-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSP

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K250542 — AC3 Range Intra-Aortic Balloon Pump2025-03-26
K232343 — AC3 Series IABP2023-08-30
K201112 — AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP2020-05-27
K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit2020-04-09
K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP)2019-11-12

Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K082746

K-number listed on FDA's recall record

Z-2298-2025 — Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon. The inner lumen is used for a guidewire and blood pressure measurement. It is packaged as a convenience kit with accessories (one-way valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, Datascope & Arrow adaptors). The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the heartbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium Component: NoClass II·Terminated·Insightra Medical Inc·20250719

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082746.

Data sourced from openFDA. This site is unofficial and independent of the FDA.