QZUClass II
Temporary Embolization Assist Device, Peripheral
21 CFR 870.3325 / Cardiovascular
QZU is the FDA product code for Temporary Embolization Assist Device, Peripheral, a class II device type, regulated under 21 CFR 870.3325. FDA's definition for this code reads: "A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature with an endovascular approach. This device is not intended to be permanently...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QZU
- Device name
- Temporary Embolization Assist Device, Peripheral
- FDA definition
- A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature 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 870.3325
- Device class
- Class II
- Review panel
- Cardiovascular
- 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 QZU
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
Applicants with the most clearances
Product code QZU| 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.