510(k) K214060
K214060 is an FDA 510(k) premarket notification submitted by Zien Medical Technologies, Inc. for the device "LANDMARK REBOA Catheter". The FDA issued a decision of Substantially Equivalent on September 19, 2022. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. Zien Medical Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2022
- Date Received
- December 27, 2021
- 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