510(k) K093551
K093551 is an FDA 510(k) premarket notification submitted by Spinemedica, LLC for the device "PARADIS VASO SHIELD". The FDA issued a decision of SESU on December 24, 2009. The device falls under product code OMR (Vessel Guard Or Cover), a Class II device regulated under 21 CFR 870.3470. Spinemedica, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- December 24, 2009
- Date Received
- November 17, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vessel Guard Or Cover
- Device Class
- Class II
- Regulation Number
- 870.3470
- Review Panel
- CV
- Submission Type
These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery. Intended to protect vessels from injury during surgery (not to be confused with wraps, patches or covers intended to facilitate revision surgeries). Indicated to wrap, patch, or cover intended to cover blood vessels.