The following data is part of a premarket notification filed by Percutaneous Systems, Inc. with the FDA for Microverter Ureteral Access Sheath.
| Device ID | K042877 |
| 510k Number | K042877 |
| Device Name: | MICROVERTER URETERAL ACCESS SHEATH |
| Classification | Accessories, Catheter, G-u |
| Applicant | PERCUTANEOUS SYSTEMS, INC. 1300 CRITTENDEN LANE # 301 Mountain View, CA 94043 |
| Contact | Thomas Lawson |
| Correspondent | Thomas Lawson PERCUTANEOUS SYSTEMS, INC. 1300 CRITTENDEN LANE # 301 Mountain View, CA 94043 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-18 |
| Decision Date | 2004-11-16 |
| Summary: | summary |