The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary Drainage Catheter.
| Device ID | K103353 |
| 510k Number | K103353 |
| Device Name: | MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Contact | Wanda Carpinella |
| Correspondent | Wanda Carpinella NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-16 |
| Decision Date | 2011-01-14 |
| Summary: | summary |