The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Heparin-coated Inqwire Diagnostic Guidewire.
| Device ID | K140608 |
| 510k Number | K140608 |
| Device Name: | MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE Ei |
| Contact | Siobhan King |
| Correspondent | Siobhan King MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE Ei |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-03-10 |
| Decision Date | 2014-09-12 |
| Summary: | summary |