Definition: Used To Obstruct Lower Aortic Blood Flow To Augment Cerebral Perfusion.
| Device Type ID | 3778 |
| Device Name | Catheter, Neuro-vasculature, Occluding Balloon |
| Physical State | A Multi-lumen Catheter With Two Balloons Mounted Near The Distal Tip |
| Technical Method | Temporary Balloon Inflation In The Descending Aortic Artery Obstructs Or Redirect Blood Flow |
| Target Area | Double Balloon Catheter Deployed In The Descending Aortic Artery And Hypothesized To Increase Cerebral Blood Flow |
| Regulation Description | Intravascular Occluding Catheter. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | HDE - Humanitarian Device Exem |
| CFR Regulation Number | 882.5150 [🔎] |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | PAV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3778 |
| Device | Catheter, Neuro-vasculature, Occluding Balloon |
| Product Code | PAV |
| Regulation Description | Intravascular Occluding Catheter. |
| CFR Regulation Number | 882.5150 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 12 |
| Total Device Problems | 12 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ZOLL Circulation, Inc. | II | Dec-03-2014 |