The following data is part of a premarket notification filed by Via Biomedical, Inc. with the FDA for Stent Graft Balloon Catheter.
| Device ID | K091624 |
| 510k Number | K091624 |
| Device Name: | STENT GRAFT BALLOON CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | VIA BIOMEDICAL, INC. 6655 WEDGEWOOD RD, SUITE 150 Maple Grove, MN 55311 |
| Contact | Fernando Di Caprio |
| Correspondent | Fernando Di Caprio VIA BIOMEDICAL, INC. 6655 WEDGEWOOD RD, SUITE 150 Maple Grove, MN 55311 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-03 |
| Decision Date | 2009-10-15 |
| Summary: | summary |