The following data is part of a premarket notification filed by Marblehead Medical with the FDA for Boss Balloon Guide Catheter.
| Device ID | K200910 |
| 510k Number | K200910 |
| Device Name: | BOSS Balloon Guide Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Marblehead Medical 11600 96th Ave N Maple Grove, MN 55369 |
| Contact | Kristin Mortenson |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-04-06 |
| Decision Date | 2020-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08600032546013 | K200910 | 000 |
| 08600032546006 | K200910 | 000 |
| 00860003254615 | K200910 | 000 |
| 00860003254608 | K200910 | 000 |