The following data is part of a premarket notification filed by Invatec S.p.a. with the FDA for Mo.ma Ultra Proximal Cerebral Protection Device, Model Mus0130069x6.
| Device ID | K092177 |
| 510k Number | K092177 |
| Device Name: | MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | INVATEC S.P.A. 3101 EMRICK BLVD Bethlehem, PA 18020 |
| Contact | Steve Camp |
| Correspondent | Steve Camp INVATEC S.P.A. 3101 EMRICK BLVD Bethlehem, PA 18020 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-21 |
| Decision Date | 2009-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033477071909 | K092177 | 000 |
| 08033477050140 | K092177 | 000 |
| 08033477090719 | K092177 | 000 |