The following data is part of a premarket notification filed by Ancora Medical Technology with the FDA for Ancora Nerve Block Catheter Set.
| Device ID | K191290 |
| 510k Number | K191290 |
| Device Name: | Ancora Nerve Block Catheter Set |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Ancora Medical Technology 333 Ravenswood Ave Menlo Park, CA 94025 |
| Contact | Chunyuan Qiu |
| Correspondent | Terri Bogucki Decus Biomedical Inc 2342 Shattuck Ave #333 Berkeley, CA 94704 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2020-02-06 |