510(k) K802288
K802288 is an FDA 510(k) premarket notification submitted by Stanco Medical, Inc. for the device "SWAN GANZ CATHETER PLACEMENT KIT". The FDA issued a decision of Substantially Equivalent on November 20, 1980. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Stanco Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 1980
- Date Received
- September 19, 1980
- 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