The following data is part of a premarket notification filed by Ppg Industries, Inc. with the FDA for Ppg Biomedical Flexible Micro Transducer Catheter.
| Device ID | K883436 |
| 510k Number | K883436 |
| Device Name: | PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | PPG INDUSTRIES, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
| Contact | John J Talarico |
| Correspondent | John J Talarico PPG INDUSTRIES, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1988-10-17 |