The following data is part of a premarket notification filed by Angiolaz, Inc. with the FDA for Angiolaz Angioscope Catheter.
| Device ID | K913129 |
| 510k Number | K913129 |
| Device Name: | ANGIOLAZ ANGIOSCOPE CATHETER |
| Classification | Angioscope |
| Applicant | ANGIOLAZ, INC. ROUTE 103 TRANSPORTATION PARK Rockingham, VT 05101 |
| Contact | Adib Khoury,m.d,m.sc |
| Correspondent | Adib Khoury,m.d,m.sc ANGIOLAZ, INC. ROUTE 103 TRANSPORTATION PARK Rockingham, VT 05101 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-16 |
| Decision Date | 1991-12-27 |