The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Silicath-ag Silicone Elastomer Foley Catheter.
| Device ID | K860362 |
| 510k Number | K860362 |
| Device Name: | SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Robert L Wilkinson |
| Correspondent | Robert L Wilkinson TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-30 |
| Decision Date | 1986-04-29 |