K974067 is an FDA 510(k) clearance for the FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE. This device is classified as a Mechanical Thrombolysis Catheter (Class II - Special Controls, product code QEY).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 27, 1998, 123 days after receiving the submission on October 27, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150. To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature..
| 510(k) Number | K974067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1997 |
| Decision Date | February 27, 1998 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QEY — Mechanical Thrombolysis Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature. |