510(k) K180959
K180959 is an FDA 510(k) premarket notification submitted by Cathera, Inc. for the device "Phenom 27 Catheter". The FDA issued a decision of Substantially Equivalent on Jun 11, 2018. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Cathera, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 11, 2018
- Date Received
- Apr 12, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)