Intera Refill Kit
FDA 510(k) clearance K213823 · decided 2022-03-16
Clearance details
- K-number
- K213823
- Device name
- Intera Refill Kit
- Applicant
- Intera Oncology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-08
- Decision date
- 2022-03-16
- Days to decision
- 98 days
- Clearance type
- Special
- Product code
- PTI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Wellesley, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.