The following data is part of a premarket notification filed by Volcano Atheromed Inc. with the FDA for Quickclear Mechanical Thrombectomy System 6f- Straight, Quickclear Mechanical Thrombectomy System 8f- Straight, Quickclear Mechanical Thrombectomy System 8f- Shaped, Quickclear Mechanical Thrombectomy System 10f- Shaped, Quickclear Aspiration Pump.
| Device ID | K193197 |
| 510k Number | K193197 |
| Device Name: | QuickClear Mechanical Thrombectomy System 6F- Straight, QuickClear Mechanical Thrombectomy System 8F- Straight, QuickClear Mechanical Thrombectomy System 8F- Shaped, QuickClear Mechanical Thrombectomy System 10F- Shaped, QuickClear Aspiration Pump |
| Classification | Catheter, Embolectomy |
| Applicant | Volcano AtheroMed Inc. 1530 O'Brien Drive, Suite A Menlo Park, CA 94025 |
| Contact | Anna Gloria Stephen |
| Correspondent | Anna Gloria Stephen Volcano AtheroMed Inc. 1530 O'Brien Drive, Suite A Menlo Park, CA 94025 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-20 |
| Decision Date | 2020-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225003142 | K193197 | 000 |
| 00845225003128 | K193197 | 000 |
| 00845225003081 | K193197 | 000 |
| 00845225003012 | K193197 | 000 |
| 00845225003005 | K193197 | 000 |
| 00845225003104 | K193197 | 000 |
| 00813132029869 | K193197 | 000 |