510(k) K881449
K881449 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116". The FDA issued a decision of Substantially Equivalent on June 15, 1988. The device falls under product code LXN (Probe, Test, Heart-Valve), a Class I device regulated under 21 CFR 870.4500. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 1988
- Date Received
- April 5, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Test, Heart-Valve
- Device Class
- Class I
- Regulation Number
- 870.4500
- Review Panel
- CV
- Submission Type