The following data is part of a premarket notification filed by Physician Technologies, Inc. with the FDA for Cathassist.
| Device ID | K052952 |
| 510k Number | K052952 |
| Device Name: | CATHASSIST |
| Classification | Accessories, Catheter, G-u |
| Applicant | PHYSICIAN TECHNOLOGIES, INC. 4932 EAST HOLBROOK STREET Anaheim, CA 92807 -1154 |
| Contact | Randall May |
| Correspondent | Randall May PHYSICIAN TECHNOLOGIES, INC. 4932 EAST HOLBROOK STREET Anaheim, CA 92807 -1154 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-20 |
| Decision Date | 2006-05-14 |