510(k) K935774
K935774 is an FDA 510(k) premarket notification submitted by Kendall Healthcare Products Co. Div.Of Tyco Health for the device "CURITY FAST-CATH FEMALE CATHETER KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on April 11, 1994. The device falls under product code EYT (Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile), a Class I device regulated under 21 CFR 876.5250. Kendall Healthcare Products Co. Div.Of Tyco Health has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- April 11, 1994
- Date Received
- December 3, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
- Device Class
- Class I
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type