The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Disposable Thoracic Catheter.
Device ID | K813587 |
510k Number | K813587 |
Device Name: | DISPOSABLE THORACIC CATHETER |
Classification | Catheter, Ventricular, General & Plastic Surgery |
Applicant | TEXAS MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GBS |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-12-28 |
Decision Date | 1982-01-12 |