510(k) K102101
K102101 is an FDA 510(k) premarket notification submitted by Surgivision, Inc. for the device "SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA". The FDA issued a decision of Substantially Equivalent on January 26, 2011. The device falls under product code HCD (Cannula, Ventricular), a Class I device regulated under 21 CFR 882.4060. Surgivision, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 2011
- Date Received
- July 27, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Ventricular
- Device Class
- Class I
- Regulation Number
- 882.4060
- Review Panel
- NE
- Submission Type