The following data is part of a premarket notification filed by Interventional Therapeutics Corp. with the FDA for Radiopaque Spherical Emboli (rse).
| Device ID | K871047 |
| 510k Number | K871047 |
| Device Name: | RADIOPAQUE SPHERICAL EMBOLI (RSE) |
| Classification | Device, Neurovascular Embolization |
| Applicant | INTERVENTIONAL THERAPEUTICS CORP. 664 SOUTH SAN MARCOS RD. Santa Barbara, CA 93111 |
| Contact | Julie D Bell |
| Correspondent | Julie D Bell INTERVENTIONAL THERAPEUTICS CORP. 664 SOUTH SAN MARCOS RD. Santa Barbara, CA 93111 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-17 |
| Decision Date | 1987-05-22 |