The following data is part of a premarket notification filed by Qxmedical, Llc with the FDA for Boosting Catheter.
Device ID | K160561 |
510k Number | K160561 |
Device Name: | Boosting Catheter |
Classification | Catheter, Percutaneous |
Applicant | QXMEDICAL, LLC 2820 PATTON ROAD Roseville, MN 55113 |
Contact | Fernando Di Caprio |
Correspondent | Fernando Di Caprio QXMEDICAL, LLC 2820 PATTON ROAD Roseville, MN 55113 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-29 |
Decision Date | 2016-11-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00853892004058 | K160561 | 000 |
00853892004041 | K160561 | 000 |
00853892004034 | K160561 | 000 |
00853892004027 | K160561 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BOOSTING CATHETER 86839516 not registered Dead/Abandoned |
QxMedical, LLC 2015-12-04 |