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 |