510(k) K221351
K221351 is an FDA 510(k) premarket notification submitted by Baylis Medical Company, Inc. for the device "Mechanical Guidewire". The FDA issued a decision of Substantially Equivalent on December 19, 2022. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Baylis Medical Company, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2022
- Date Received
- May 10, 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