510(k) K965189
K965189 is an FDA 510(k) premarket notification submitted by Target Therapeutics for the device "SPINNAKER". The FDA issued a decision of Substantially Equivalent on March 24, 1997. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Target Therapeutics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1997
- Date Received
- December 24, 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