510(k) K221832
K221832 is an FDA 510(k) premarket notification submitted by Cordis US Corp for the device "SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on August 22, 2022. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Cordis US Corp has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2022
- Date Received
- June 23, 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