PUUClass II
Temporary Coil Embolization Assist Device
21 CFR 882.5955 / Neurology
PUU is the FDA product code for Temporary Coil Embolization Assist Device, a class II device type, regulated under 21 CFR 882.5955. FDA's definition for this code reads: "A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PUU
- Device name
- Temporary Coil Embolization Assist Device
- FDA definition
- A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.
- Regulation
- 21 CFR 882.5955
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code PUU
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2019 | 1 |
Applicants with the most clearances
Product code PUU| Applicant | Clearances |
|---|---|
| Rapid Medical Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.