The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Asaplp Aspiration Catheter.
| Device ID | K132155 |
| 510k Number | K132155 |
| Device Name: | ASAPLP ASPIRATION CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Susan Christensen |
| Correspondent | Susan Christensen 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 | 2013-07-12 |
| Decision Date | 2013-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450329303 | K132155 | 000 |
| 10884450160579 | K132155 | 000 |
| 10884450511746 | K132155 | 000 |