The following data is part of a premarket notification filed by Acclarent Inc. with the FDA for Next Generation Balloon Dilation System.
| Device ID | K201115 |
| 510k Number | K201115 |
| Device Name: | Next Generation Balloon Dilation System |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | Acclarent Inc. 31 Technology Dr., Suite 200 Irvine, CA 92618 |
| Contact | David Locke |
| Correspondent | David Locke Acclarent Inc. 31 Technology Dr., Suite 200 Irvine, CA 92618 |
| Product Code | LRC |
| Subsequent Product Code | PGW |
| Subsequent Product Code | PNZ |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-27 |
| Decision Date | 2020-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031465616 | K201115 | 000 |
| 20705031465609 | K201115 | 000 |
| 20705031465586 | K201115 | 000 |
| 20705031465593 | K201115 | 000 |
| 20705031465579 | K201115 | 000 |
| 20705031465562 | K201115 | 000 |