The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Minnie Support Catheter.
Device ID | K082337 |
510k Number | K082337 |
Device Name: | MINNIE SUPPORT CATHETER |
Classification | Catheter, Percutaneous |
Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
Contact | Charmaine Sutton |
Correspondent | Charmaine Sutton VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-08-14 |
Decision Date | 2009-01-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M20657130 | K082337 | 000 |
M20657000 | K082337 | 000 |
30841156100814 | K082337 | 000 |
30841156100807 | K082337 | 000 |
30841156100791 | K082337 | 000 |
30841156100784 | K082337 | 000 |
30841156100777 | K082337 | 000 |
30841156100760 | K082337 | 000 |
30841156100753 | K082337 | 000 |
M20657010 | K082337 | 000 |
M20657020 | K082337 | 000 |
M20657030 | K082337 | 000 |
M20657120 | K082337 | 000 |
M20657110 | K082337 | 000 |
M20657100 | K082337 | 000 |
M20657080 | K082337 | 000 |
M20657070 | K082337 | 000 |
M20657060 | K082337 | 000 |
M20657050 | K082337 | 000 |
M20657040 | K082337 | 000 |
30841156100746 | K082337 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MINNIE SUPPORT CATHETER 77447309 3617271 Dead/Cancelled |
Vascular Solutions, Inc. 2008-04-14 |