The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Modified Foley Catheter.
| Device ID | K863302 |
| 510k Number | K863302 |
| Device Name: | MODIFIED FOLEY CATHETER |
| Classification | Catheter, Urological |
| Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
| Contact | Steen, Ph.d. |
| Correspondent | Steen, Ph.d. SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-25 |
| Decision Date | 1986-10-03 |