The following data is part of a premarket notification filed by Peripheral Systems Group with the FDA for Apex(tm) Prostatic Balloon Dilation Catheter.
| Device ID | K913477 |
| 510k Number | K913477 |
| Device Name: | APEX(TM) PROSTATIC BALLOON DILATION CATHETER |
| Classification | Dilator, Urethral |
| Applicant | PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Jessica Ayres |
| Correspondent | Jessica Ayres PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Product Code | KOE |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-05 |
| Decision Date | 1991-12-27 |