510(k) K192422
K192422 is an FDA 510(k) premarket notification submitted by Freudenberg Medical, LLC for the device "Steerable Introducer 12F". The FDA issued a decision of Substantially Equivalent on October 4, 2019. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Freudenberg Medical, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 2019
- Date Received
- September 4, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Steerable
- Device Class
- Class II
- Regulation Number
- 870.1280
- Review Panel
- CV
- Submission Type