The following data is part of a premarket notification filed by Percutaneous Systems, Incorporated with the FDA for Expressway Intermittent Catheter.
| Device ID | K061766 |
| 510k Number | K061766 |
| Device Name: | EXPRESSWAY INTERMITTENT CATHETER |
| Classification | Catheter, Straight |
| Applicant | PERCUTANEOUS SYSTEMS, INCORPORATED 1300 CRITTENDEN LANE SUITE 101 Mountain View, CA 94043 |
| Contact | Thomas Lawson |
| Correspondent | Thomas Lawson PERCUTANEOUS SYSTEMS, INCORPORATED 1300 CRITTENDEN LANE SUITE 101 Mountain View, CA 94043 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-22 |
| Decision Date | 2007-03-09 |
| Summary: | summary |