The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Concentric Embolic Pearls.
| Device ID | K050470 |
| 510k Number | K050470 |
| Device Name: | CONCENTRIC EMBOLIC PEARLS |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | CONCENTRIC MEDICAL, INC. 1380 SHOREBIRD WAY Mountain View, CA 94043 |
| Contact | Jean M Caillouette |
| Correspondent | Jean M Caillouette CONCENTRIC MEDICAL, INC. 1380 SHOREBIRD WAY Mountain View, CA 94043 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-23 |
| Decision Date | 2005-05-06 |
| Summary: | summary |