The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Asap Aspiration Catheter, Asaplp Aspiration Catheter.
| Device ID | K212199 |
| 510k Number | K212199 |
| Device Name: | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter |
| Classification | Aspiration Thrombectomy Catheter |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Kirk Mcintosh |
| Correspondent | Kirk Mcintosh Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | QEZ |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-14 |
| Decision Date | 2021-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450555122 | K212199 | 000 |
| 10884450568382 | K212199 | 000 |