The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Piggyback Wire Converter.
Device ID | K090977 |
510k Number | K090977 |
Device Name: | PIGGYBACK WIRE CONVERTER |
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 | 2009-04-06 |
Decision Date | 2009-06-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M20688020 | K090977 | 000 |
M20688010 | K090977 | 000 |
M20688000 | K090977 | 000 |
30841156101651 | K090977 | 000 |