510(k) K961294
K961294 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED DISPATCH GOLD CORONARY CATHETER". The FDA issued a decision of Substantially Equivalent on Jul 3, 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 108 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 3, 1996
- Date Received
- Apr 4, 1996
- 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
- 510(k)