The following data is part of a premarket notification filed by Avantec Vascular Corporation with the FDA for Captus Vascular Retrieval System.
| Device ID | K170987 |
| 510k Number | K170987 |
| Device Name: | Captus Vascular Retrieval System |
| Classification | Device, Percutaneous Retrieval |
| Applicant | Avantec Vascular Corporation 605 W. California Avenue Sunnyvale, CA 94086 |
| Contact | Nicholas Debeer |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, CA 92104 |
| Product Code | MMX |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-03 |
| Decision Date | 2017-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B342CAP14120 | K170987 | 000 |