Catheter, Neurovasculature, Occluding Balloon
NUF is the FDA product code for Catheter, Neurovasculature, Occluding Balloon, a class III device type, regulated under 21 CFR 882.5150. FDA's definition for this code reads: "Call for PMAs - 12/26/96 per 61 FR 50708 on 9/27/96 - For the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- NUF
- Device name
- Catheter, Neurovasculature, Occluding Balloon
- FDA definition
- Call for PMAs - 12/26/96 per 61 FR 50708 on 9/27/96 - For the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management
- Regulation
- 21 CFR 882.5150
- Device class
- Class III
- Review panel
- Neurology
- Submission type
- PMA
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code NUF.
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