510(k) K953133
K953133 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED DISPATCH CORONARY INFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on February 23, 1996. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Scimed Life Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 1996
- Date Received
- July 6, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Continuous Flush
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type