The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Safety Introducer Needle.
| Device ID | K140513 |
| 510k Number | K140513 |
| Device Name: | MERIT SAFETY INTRODUCER NEEDLE |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-28 |
| Decision Date | 2014-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450017989 | K140513 | 000 |
| 20884450017924 | K140513 | 000 |
| 20884450016606 | K140513 | 000 |
| 20884450016583 | K140513 | 000 |