The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Sofia Distal Access Catheter.
Device ID | K131482 |
510k Number | K131482 |
Device Name: | SOFIA DISTAL ACCESS CATHETER |
Classification | Catheter, Percutaneous |
Applicant | MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
Contact | Naomi Gong |
Correspondent | Naomi Gong MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-23 |
Decision Date | 2013-11-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04987350999795 | K131482 | 000 |
00816777025913 | K131482 | 000 |
00810170019623 | K131482 | 000 |
00810170019234 | K131482 | 000 |