The following data is part of a premarket notification filed by Marblehead Medical Llc with the FDA for Boss 8f Balloon Guide Catheter.
| Device ID | K203840 |
| 510k Number | K203840 |
| Device Name: | BOSS 8F Balloon Guide Catheter |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Marblehead Medical LLC 753 Fox Chase Rd SW Rochester Mn, MN 55902 -8749 |
| Contact | Kristin M. Mortenson |
| Correspondent | Kristin M. Mortenson Marblehead Medical LLC 753 Fox Chase Rd SW Rochester Mn, MN 55902 -8749 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-31 |
| Decision Date | 2021-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000491789 | K203840 | 000 |
| 00763000491772 | K203840 | 000 |