K991619 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 June 9, 1999, 29 days after receiving the submission on May 11, 1999.
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 | K991619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1999 |
| Decision Date | June 09, 1999 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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. |