The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for 5.5 F Worley Advanced Lvi Lateral Vein Introducer.
| Device ID | K152116 |
| 510k Number | K152116 |
| Device Name: | 5.5 F Worley Advanced LVI Lateral Vein 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 | 2015-07-30 |
| Decision Date | 2015-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450284657 | K152116 | 000 |
| 10884450284640 | K152116 | 000 |
| 10884450284633 | K152116 | 000 |
| 10884450284589 | K152116 | 000 |
| 10884450404055 | K152116 | 000 |
| 10884450483944 | K152116 | 000 |
| 10884450483951 | K152116 | 000 |
| 10884450483937 | K152116 | 000 |
| 10884450483920 | K152116 | 000 |