The following data is part of a premarket notification filed by Balt Usa, Llc with the FDA for Eclipse 2l.
| Device ID | K183045 |
| 510k Number | K183045 |
| Device Name: | Eclipse 2L |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | Balt USA, LLC 29 Parker Irvine, CA 92618 |
| Contact | Nancy Xu |
| Correspondent | Nancy Xu Balt USA, LLC 29 Parker Irvine, CA 92618 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-02 |
| Decision Date | 2019-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818053023002 | K183045 | 000 |
| 00818053022982 | K183045 | 000 |
| 00818053022968 | K183045 | 000 |
| 00818053022944 | K183045 | 000 |
| 00818053022937 | K183045 | 000 |
| 00818053022920 | K183045 | 000 |