The following data is part of a premarket notification filed by Pluromed, Inc. with the FDA for Backstop Catheter.
| Device ID | K103349 |
| 510k Number | K103349 |
| Device Name: | BACKSTOP CATHETER |
| Classification | Catheter, Urological |
| Applicant | PLUROMED, INC. 25-H OLYMPIA AVENUE Woburn, MA 01801 |
| Contact | James Wilkie |
| Correspondent | James Wilkie PLUROMED, INC. 25-H OLYMPIA AVENUE Woburn, MA 01801 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-16 |
| Decision Date | 2011-01-07 |
| Summary: | summary |