The following data is part of a premarket notification filed by Boston Scientific with the FDA for Embozene Color-advanced Microspheres.
| Device ID | K180102 |
| 510k Number | K180102 |
| Device Name: | Embozene Color-Advanced Microspheres |
| Classification | Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia |
| Applicant | Boston Scientific 3 Scimed Place Maple Grove, MN 55311 |
| Contact | Heidi Shearer |
| Correspondent | Heidi Shearer Boston Scientific 3 Scimed Place Maple Grove, MN 55311 |
| Product Code | NOY |
| Subsequent Product Code | KRD |
| Subsequent Product Code | NAJ |
| CFR Regulation Number | 876.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-16 |
| Decision Date | 2018-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810563021578 | K180102 | 000 |
| 00810563021141 | K180102 | 000 |
| 00810563021134 | K180102 | 000 |
| 00810563021127 | K180102 | 000 |
| 00810563021110 | K180102 | 000 |
| 00810563021103 | K180102 | 000 |
| 00810563021097 | K180102 | 000 |
| 00810563021080 | K180102 | 000 |
| 00810563021073 | K180102 | 000 |
| 00810563021158 | K180102 | 000 |
| 00810563021486 | K180102 | 000 |
| 00810563021561 | K180102 | 000 |
| 00810563021554 | K180102 | 000 |
| 00810563021547 | K180102 | 000 |
| 00810563021530 | K180102 | 000 |
| 00810563021523 | K180102 | 000 |
| 00810563021516 | K180102 | 000 |
| 00810563021509 | K180102 | 000 |
| 00810563021493 | K180102 | 000 |
| 00810563021066 | K180102 | 000 |