The following data is part of a premarket notification filed by Ivalon with the FDA for Ivalon Embolization Particles.
| Device ID | K913556 |
| 510k Number | K913556 |
| Device Name: | IVALON EMBOLIZATION PARTICLES |
| Classification | Device, Neurovascular Embolization |
| Applicant | IVALON 5374 LINDA VISTA RD., SUITE C San Diego, CA 92110 |
| Contact | Elizabeth Melaragno |
| Correspondent | Elizabeth Melaragno IVALON 5374 LINDA VISTA RD., SUITE C San Diego, CA 92110 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-09 |
| Decision Date | 1994-04-13 |