Altaviz Needle Kit
FDA 510(k) clearance K222681 · decided 2022-12-05
Clearance details
- K-number
- K222681
- Device name
- Altaviz Needle Kit
- Applicant
- Altaviz, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-09-06
- Decision date
- 2022-12-05
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or recall (Z-2653-2023) | Apellis Pharmaceuticals, Inc. | 2023-09-29 |