The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Areustm Endobronchial Ultrasound Aspiration Needle, Tridenttm Endobronchial Ultrasound Aspiration Needle.
| Device ID | K213060 |
| 510k Number | K213060 |
| Device Name: | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle |
| Classification | Bronchoscope Accessory |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. No. 10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing, CN 210032 |
| Contact | Sally He |
| Correspondent | Sally He Micro-Tech (Nanjing) Co., Ltd. No. 10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing, CN 210032 |
| Product Code | KTI |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-22 |
| Decision Date | 2022-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503549254 | K213060 | 000 |
| 16932503549247 | K213060 | 000 |
| 16932503549230 | K213060 | 000 |
| 16932503549223 | K213060 | 000 |
| 16932503549216 | K213060 | 000 |
| 16932503549261 | K213060 | 000 |