The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Endomaxx Fully Covered Esophageal Stent.
| Device ID | K111611 |
| 510k Number | K111611 |
| Device Name: | ENDOMAXX FULLY COVERED ESOPHAGEAL STENT |
| Classification | Prosthesis, Esophageal |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 -2415 |
| Contact | John C Knorpp |
| Correspondent | John C Knorpp MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 -2415 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-09 |
| Decision Date | 2011-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450147648 | K111611 | 000 |
| 10884450442293 | K111611 | 000 |
| 10884450442378 | K111611 | 000 |
| 10884450442255 | K111611 | 000 |
| 10884450442231 | K111611 | 000 |
| 10884450442330 | K111611 | 000 |
| 10884450442316 | K111611 | 000 |
| 10884450442354 | K111611 | 000 |
| 10884450093044 | K111611 | 000 |
| 10884450093068 | K111611 | 000 |
| 10884450093082 | K111611 | 000 |
| 10884450093105 | K111611 | 000 |
| 10884450147617 | K111611 | 000 |
| 10884450147624 | K111611 | 000 |
| 10884450147631 | K111611 | 000 |
| 10884450442279 | K111611 | 000 |