The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Introduction/drainage Catheter & Access.
| Device ID | K881873 |
| 510k Number | K881873 |
| Device Name: | INTRODUCTION/DRAINAGE CATHETER & ACCESS |
| Classification | Catheter, Ventricular, General & Plastic Surgery |
| Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
| Contact | Steen, Phd |
| Correspondent | Steen, Phd 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 | 1988-05-03 |
| Decision Date | 1988-05-18 |