510(k) K191469
K191469 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "Biotronik Stylets". The FDA issued a decision of Substantially Equivalent on August 1, 2019. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. Biotronik, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2019
- Date Received
- June 3, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stylet, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1380
- Review Panel
- CV
- Submission Type