The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Truefill Pva Particles.
| Device ID | K951314 |
| 510k Number | K951314 |
| Device Name: | TRUEFILL PVA PARTICLES |
| Classification | Device, Neurovascular Embolization |
| Applicant | CORDIS NEUROVASCULAR, INC. 14740 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Marlene W Valenti |
| Correspondent | Marlene W Valenti CORDIS NEUROVASCULAR, INC. 14740 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-23 |
| Decision Date | 1995-08-08 |