Insightra Medical Inc
Clarksville, TN, US
INSIGHTRA MEDICAL, INC. appears in FDA device records in Clarksville, TN. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Insightra Medical Inc between 2009 and 2015. The busiest year on record is 2009, with 1. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K142192 | Insightra Freedom Ventral Hernia Repair System | FTL | Substantially Equivalent | |
| K140967 | FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK | FTL | Substantially Equivalent | |
| K113552 | FREEDOM INGUINAL HERNIA IMPLANT | FTL | Substantially Equivalent | |
| K082746 | ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 | DSP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2032677 | 3003945344 | INSIGHTRA MEDICAL, INC. | 2543 Madison St, Clarksville, TN 37043 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- KGZAccessories, Catheter
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- HRXArthroscope
- KMKDevice, Intravascular Catheter Securement
- ODBEndoscopic Contamination Prevention Sheath
- MDMInstrument, Manual, Surgical, General Use
- FHNLigator, Hemorrhoidal
- FTLMesh, Surgical, Polymeric
- GADRetractor
- PTMSyringe, Balloon Inflation, Exempt
- DSPSystem, Balloon, Intra-Aortic And Control
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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: No | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain