The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Preludeease Hydrophilic Sheath Introducer.
| Device ID | K140543 |
| 510k Number | K140543 |
| Device Name: | PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Michaela Rivkowich |
| Correspondent | Michaela Rivkowich 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 | 2014-03-04 |
| Decision Date | 2014-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450257931 | K140543 | 000 |
| 20884450524606 | K140543 | 000 |
| 20884450526006 | K140543 | 000 |
| 20884450526297 | K140543 | 000 |
| 20884450526327 | K140543 | 000 |
| 20884450525993 | K140543 | 000 |
| 20884450526198 | K140543 | 000 |
| 20884450526167 | K140543 | 000 |
| 20884450526389 | K140543 | 000 |
| 20884450524330 | K140543 | 000 |
| 20884450526341 | K140543 | 000 |
| 20884450525979 | K140543 | 000 |
| 20884450525511 | K140543 | 000 |
| 20884450257924 | K140543 | 000 |
| 20884450333826 | K140543 | 000 |
| 20884450289215 | K140543 | 000 |
| 20884450526143 | K140543 | 000 |
| 20884450526150 | K140543 | 000 |
| 20884450525986 | K140543 | 000 |
| 20884450525566 | K140543 | 000 |
| 20884450526181 | K140543 | 000 |
| 20884450526105 | K140543 | 000 |
| 20884450526112 | K140543 | 000 |
| 20884450526334 | K140543 | 000 |