The following data is part of a premarket notification filed by Disccath Llc with the FDA for Disccath Needle Set.
| Device ID | K212328 |
| 510k Number | K212328 |
| Device Name: | DiscCath Needle Set |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | DiscCath LLC 62 E 88th Street New York, NY 10128 |
| Contact | Gregory E. Lutz |
| Correspondent | Gregory E. Lutz DiscCath LLC 62 E 88th Street New York, NY 10128 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-27 |
| Decision Date | 2021-09-26 |