The following data is part of a premarket notification filed by Control Medical Technology, Llc with the FDA for Aspire Max Aspiration Catheter.
| Device ID | K113757 |
| 510k Number | K113757 |
| Device Name: | ASPIRE MAX ASPIRATION CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | CONTROL MEDICAL TECHNOLOGY, LLC 136 HEBER AVENUE, SUITE 101, PO BOX 681013 Park City, UT 84068 |
| Contact | Shawn P Fojtik |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-12-21 |
| Decision Date | 2012-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B090A61352 | K113757 | 000 |
| B090A60550 | K113757 | 000 |
| B090A51352 | K113757 | 000 |
| B090A50552 | K113757 | 000 |