510(k) K093489
K093489 is an FDA 510(k) premarket notification submitted by Rymed Technologies, Inc. for the device "IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY". The FDA issued a decision of Substantially Equivalent on July 29, 2010. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Rymed Technologies, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2010
- Date Received
- November 10, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type