The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Embolectomy Catheter Model Asap100.
Device ID | K100569 |
510k Number | K100569 |
Device Name: | MERIT EMBOLECTOMY CATHETER MODEL ASAP100 |
Classification | Catheter, Embolectomy |
Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
Contact | Lindsay Martin |
Correspondent | Lindsay Martin MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
Product Code | DXE |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-03-01 |
Decision Date | 2011-03-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884450033002 | K100569 | 000 |
10884450437268 | K100569 | 000 |
10884450511715 | K100569 | 000 |
10884450511708 | K100569 | 000 |