510(k) K200266
K200266 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. (Bard Has Joined Bd) for the device "BD Centro Vena Acute Central Line (7 French Dual Lumen)". The FDA issued a decision of Substantially Equivalent on Apr 7, 2020. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Bard Access Systems, Inc. (Bard Has Joined Bd) has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 7, 2020
- Date Received
- Feb 3, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type
- 510(k)