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 |