510(k) K935404
K935404 is an FDA 510(k) premarket notification submitted by J-Lloyd Medical, Inc. for the device "FLOW DIRECTED THERMODILUTION BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on May 3, 1994. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. J-Lloyd Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 1994
- Date Received
- November 9, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Flow Directed
- Device Class
- Class II
- Regulation Number
- 870.1240
- Review Panel
- CV
- Submission Type