510(k) K223177
K223177 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Highlander 014 PTA Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on January 20, 2023. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 2023
- Date Received
- October 11, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type