The following data is part of a premarket notification filed by Percutaneous Systems, Inc. with the FDA for Cystoglide Dilating Introducer Sheath.
| Device ID | K052134 |
| 510k Number | K052134 |
| Device Name: | CYSTOGLIDE DILATING INTRODUCER SHEATH |
| Classification | Accessories, Catheter, G-u |
| Applicant | PERCUTANEOUS SYSTEMS, INC. 1300 CRITTENDEN LANE SUITE 101 Mountain View, CA 94043 -1359 |
| Contact | Thomas Lawson |
| Correspondent | Thomas Lawson PERCUTANEOUS SYSTEMS, INC. 1300 CRITTENDEN LANE SUITE 101 Mountain View, CA 94043 -1359 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-05 |
| Decision Date | 2005-09-22 |
| Summary: | summary |