510(k) K150882
K150882 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Edwards Suture Fastening System". The FDA issued a decision of Substantially Equivalent on June 16, 2015. The device falls under product code HCF (Instrument, Ligature Passing And Knot Tying), a Class I device regulated under 21 CFR 878.4800. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2015
- Date Received
- April 2, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ligature Passing And Knot Tying
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type