The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Ascent Occlusion Balloon Catheter 4x7 Mm; Micrus Ascent Occlusion Balloon Catheter 6x9 Mm; Micrus Summit Occlusio.
| Device ID | K103780 |
| 510k Number | K103780 |
| Device Name: | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
| Contact | Patrick Lee |
| Correspondent | Patrick Lee MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-27 |
| Decision Date | 2011-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00878528001935 | K103780 | 000 |
| 00878528001928 | K103780 | 000 |
| 00878528001911 | K103780 | 000 |
| 00878528001904 | K103780 | 000 |