The following data is part of a premarket notification filed by Percuvision Llc with the FDA for Percucath Urinary Catheter.
| Device ID | K090262 |
| 510k Number | K090262 |
| Device Name: | PERCUCATH URINARY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | PERCUVISION LLC 765 NORTH HAMILTON RD. SUITE 260A Gahanna, OH 43230 |
| Contact | Errol Singh |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-02-03 |
| Decision Date | 2009-05-28 |
| Summary: | summary |