The following data is part of a premarket notification filed by Balt Usa Llc with the FDA for Ballast 088 Long Sheath.
| Device ID | K182918 |
| 510k Number | K182918 |
| Device Name: | Ballast 088 Long Sheath |
| Classification | Catheter, Percutaneous |
| Applicant | Balt USA LLC 29 Parker Irvine, CA 92618 |
| Contact | Bilal Chamas |
| Correspondent | Charles Yang Balt USA LLC 29 Parker Irvine, CA 92618 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-19 |
| Decision Date | 2019-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818053022913 | K182918 | 000 |
| 00818053022906 | K182918 | 000 |
| 00818053022890 | K182918 | 000 |
| 00818053022883 | K182918 | 000 |