510(k) K221390
K221390 is an FDA 510(k) premarket notification submitted by Biomerics Nle for the device "BNLE Access Guidewire". The FDA issued a decision of Substantially Equivalent on April 28, 2023. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Biomerics Nle has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2023
- Date Received
- May 13, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type