The following data is part of a premarket notification filed by Balt Usa, Llc with the FDA for Hybrid Guidewire.
| Device ID | K182337 |
| 510k Number | K182337 |
| Device Name: | HYBRID Guidewire |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | Balt USA, LLC 29 Parker Irvine, CA 92618 |
| Contact | Nancy Xu |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-08-28 |
| Decision Date | 2018-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818053022852 | K182337 | 000 |
| 00818053022746 | K182337 | 000 |
| 00818053022753 | K182337 | 000 |
| 00818053022760 | K182337 | 000 |
| 00818053022777 | K182337 | 000 |
| 00818053022784 | K182337 | 000 |
| 00818053022791 | K182337 | 000 |
| 00818053022807 | K182337 | 000 |
| 00818053022814 | K182337 | 000 |
| 00818053022739 | K182337 | 000 |