The following data is part of a premarket notification filed by Merit Medical Systems with the FDA for Prelude Ideal 9f Hydrophilic Sheath Introducer.
| Device ID | K212152 |
| 510k Number | K212152 |
| Device Name: | Prelude IDeal 9F Hydrophilic Sheath Introducer |
| Classification | Introducer, Catheter |
| Applicant | Merit Medical Systems 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | David Thomas |
| Correspondent | David Thomas Merit Medical Systems 1600 West Merit Parkway 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 | 2021-07-09 |
| Decision Date | 2022-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884450552148 | K212152 | 000 |
| 00884450552131 | K212152 | 000 |