The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter.
| Device ID | K152069 |
| 510k Number | K152069 |
| Device Name: | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Contact | Michael P. Hanley |
| Correspondent | Michael P. Hanley NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-27 |
| Decision Date | 2015-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965105901 | K152069 | 000 |
| H965105271 | K152069 | 000 |
| H965105261 | K152069 | 000 |
| H965105251 | K152069 | 000 |
| H965105241 | K152069 | 000 |
| H965105221 | K152069 | 000 |
| H965105211 | K152069 | 000 |
| H965105201 | K152069 | 000 |
| H965105181 | K152069 | 000 |
| H965105161 | K152069 | 000 |
| H965105141 | K152069 | 000 |
| H965105121 | K152069 | 000 |
| H965105281 | K152069 | 000 |
| H965105291 | K152069 | 000 |
| H965105811 | K152069 | 000 |
| H965105801 | K152069 | 000 |
| H965105721 | K152069 | 000 |
| H965105711 | K152069 | 000 |
| H965105621 | K152069 | 000 |
| H965105501 | K152069 | 000 |
| H965105411 | K152069 | 000 |
| H965105401 | K152069 | 000 |
| H965105321 | K152069 | 000 |
| H965105311 | K152069 | 000 |
| H965105301 | K152069 | 000 |
| H965105101 | K152069 | 000 |