510(k) K203275
K203275 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Recon Support Catheter". The FDA issued a decision of Substantially Equivalent on March 1, 2021. The device falls under product code DQY (Catheter, Percutaneous), 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
- March 1, 2021
- Date Received
- November 6, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type