The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Prelude Snap Splittable Hydrophilic Sheath Introducer.
| Device ID | K152381 |
| 510k Number | K152381 |
| Device Name: | Prelude SNAP Splittable Hydrophilic Sheath Introducer |
| Classification | Introducer, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 65 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Contact | Alina Stubbs |
| Correspondent | Alina Stubbs MERIT MEDICAL SYSTEMS, INC. 65 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-24 |
| Decision Date | 2015-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884450495049 | K152381 | 000 |
| 10884450274429 | K152381 | 000 |
| 10884450274436 | K152381 | 000 |
| 10884450274443 | K152381 | 000 |
| 10884450274450 | K152381 | 000 |
| 10884450274467 | K152381 | 000 |
| 10884450274474 | K152381 | 000 |
| 10884450274481 | K152381 | 000 |
| 10884450274498 | K152381 | 000 |
| 10884450274412 | K152381 | 000 |
| 00884450495100 | K152381 | 000 |
| 00884450495056 | K152381 | 000 |
| 00884450495452 | K152381 | 000 |
| 00884450495506 | K152381 | 000 |
| 00884450495490 | K152381 | 000 |
| 00884450495469 | K152381 | 000 |
| 00884450495476 | K152381 | 000 |
| 00884450495445 | K152381 | 000 |
| 00884450495087 | K152381 | 000 |
| 10884450274504 | K152381 | 000 |
| 10884450274511 | K152381 | 000 |
| 10884450274528 | K152381 | 000 |
| 10884450280833 | K152381 | 000 |
| 10884450280857 | K152381 | 000 |
| 10884450280871 | K152381 | 000 |
| 10884450280895 | K152381 | 000 |
| 10884450280956 | K152381 | 000 |
| 10884450280970 | K152381 | 000 |
| 10884450280994 | K152381 | 000 |
| 10884450281014 | K152381 | 000 |
| 10884450280819 | K152381 | 000 |
| 10884450280772 | K152381 | 000 |
| 10884450274535 | K152381 | 000 |
| 10884450274542 | K152381 | 000 |
| 10884450274559 | K152381 | 000 |
| 10884450274566 | K152381 | 000 |
| 10884450274573 | K152381 | 000 |
| 10884450274580 | K152381 | 000 |
| 10884450280758 | K152381 | 000 |
| 10884450280765 | K152381 | 000 |
| 10884450281052 | K152381 | 000 |