510(k) K190855
K190855 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. (Bard Has Joined Bd) for the device "BD Acute Central Line". The FDA issued a decision of Substantially Equivalent on Nov 1, 2019. 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
- Nov 1, 2019
- Date Received
- Apr 2, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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)