K213823 is an FDA 510(k) clearance for the Intera Refill Kit. This device is classified as a Non-coring (huber) Needle (Class II - Special Controls, product code PTI).
Submitted by Intera Oncology, Inc. (Wellesley, US). The FDA issued a Cleared decision on March 16, 2022, 98 days after receiving the submission on December 8, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570. The Non-coring Needle (huber) Is Utilized To Gain Access Into A Subcutaneous Implanted Intravascular Infusion Port But Can Also Be Used To Access Other Non-vascular Implanted Devices With Similar Septums..
| 510(k) Number | K213823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2021 |
| Decision Date | March 16, 2022 |
| Days to Decision | 98 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PTI - Non-coring (huber) Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
| Definition | The Non-coring Needle (huber) Is Utilized To Gain Access Into A Subcutaneous Implanted Intravascular Infusion Port But Can Also Be Used To Access Other Non-vascular Implanted Devices With Similar Septums. |