The following data is part of a premarket notification filed by Protein Polymer Technologies, Inc. with the FDA for Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization Particles.
| Device ID | K061790 |
| 510k Number | K061790 |
| Device Name: | PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | PROTEIN POLYMER TECHNOLOGIES, INC. 10655 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Contact | Radine Pobuda |
| Correspondent | Radine Pobuda PROTEIN POLYMER TECHNOLOGIES, INC. 10655 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-26 |
| Decision Date | 2006-09-19 |
| Summary: | summary |