The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Deknatel(tm) Pleur-evac(r) Thoracic Catheter.
| Device ID | K925243 |
| 510k Number | K925243 |
| Device Name: | DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER |
| Classification | Catheter, Irrigation |
| Applicant | DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Contact | Michael Santalucia |
| Correspondent | Michael Santalucia DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-16 |
| Decision Date | 1994-07-27 |