EYT
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5250
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1992: 6 · 1993: 2 · 1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| URINARY DRAINAGE BAG (K934080) | Kit Pak, Inc. | 1994-05-18 |
| CURITY FAST-CATH FEMALE CATHETER KIT (K935774) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1994-04-11 |
| COMFORT CATH MALE EXTERNAL CATHETER (K883057) | Sierra Laboratories, Inc. | 1988-08-02 |
| VPI NON-ADHESIVE CONDOM CATHETER (K883119) | Cook Urological, Inc. | 1988-08-02 |
Track EYT automatically
Every clearance here is in the API, with alerts when new ones post.