The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Thoracic Catheter (chest Drainage Tube).
Device ID | K863142 |
510k Number | K863142 |
Device Name: | THORACIC CATHETER (CHEST DRAINAGE TUBE) |
Classification | Catheter, Ventricular, General & Plastic Surgery |
Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
Contact | John Steen |
Correspondent | John Steen SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
Product Code | GBS |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-15 |
Decision Date | 1986-08-29 |