510(k) K183045
K183045 is an FDA 510(k) premarket notification submitted by Balt USA, LLC for the device "Eclipse 2L". The FDA issued a decision of Substantially Equivalent on April 30, 2019. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. Balt USA, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2019
- Date Received
- November 2, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular Occluding, Temporary
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type