510(k) K861985
K861985 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)". The FDA issued a decision of Substantially Equivalent on December 4, 1986. The device falls under product code MVR (Device, Anastomotic, Microvascular), a Class II device regulated under 21 CFR 878.4300. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1986
- Date Received
- May 22, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anastomotic, Microvascular
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type