The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Curity Fast-cath Female Catheter Kit.
| Device ID | K935774 |
| 510k Number | K935774 |
| Device Name: | CURITY FAST-CATH FEMALE CATHETER KIT |
| Classification | Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | David A Olson |
| Correspondent | David A Olson KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | EYT |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-03 |
| Decision Date | 1994-04-11 |