The following data is part of a premarket notification filed by Cardiac Assist Devices, Inc. with the FDA for Gyro-tip Lariat Deflectable Loop Mapping Catheter, Model Gtl-20e.
| Device ID | K012520 |
| 510k Number | K012520 |
| Device Name: | GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | CARDIAC ASSIST DEVICES, INC. 11000 CEDAR AVE., SUITE 451 Cleveland, OH 44106 -3052 |
| Contact | Rassoll Rashidi |
| Correspondent | Rassoll Rashidi CARDIAC ASSIST DEVICES, INC. 11000 CEDAR AVE., SUITE 451 Cleveland, OH 44106 -3052 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2002-03-27 |
| Summary: | summary |