510(k) clearance
Reprocessed BRK Transseptal Needle
- 510(k) number
- K262917
- Applicant
- Innovative Health, LLC
- Decision date
- Oct 19, 2026
- Date received
- Aug 20, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NMK
- Device type
- Trocar, Reprocessed
- Device class
- Class II
- Regulation
- 21 CFR 870.1390
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Scottsdale, AZ, US