510(k) K250529
K250529 is an FDA 510(k) premarket notification submitted by Kardium, Inc. for the device "Globe Introducer (601-01001)". The FDA issued a decision of Substantially Equivalent on June 3, 2025. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Kardium, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2025
- Date Received
- February 24, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Steerable
- Device Class
- Class II
- Regulation Number
- 870.1280
- Review Panel
- CV
- Submission Type