510(k) clearances

Reprocessed BRK Transseptal Needle

Innovative Health, LLC · Cardiovascular

K262917Substantially EquivalentTraditionalNMK
Open FDA's page for this record
Third party flag
N
City
Scottsdale
Advisory committee description
Cardiovascular
Address 1
1435 N. Hayden Rd.
Address 2
Suite 100
Statement or summary
Summary
Product code
NMK
Zip code
85257
Applicant
Innovative Health, LLC
Decision date
2026-10-19
Decision code
SESE
Country code
US
Device name
Reprocessed BRK Transseptal Needle
Advisory committee
CV
Contact
Rick Ferreira
K number
K262917
State
AZ
Date received
2026-08-20
Review advisory committee
CV
Postal code
85257
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Trocar, Reprocessed
Medical specialty description
Cardiovascular
Regulation number
870.1390
Device class
2
Registration number
3011610434, 2032112, 1422634
FEI number
1000514656, 3011610434, 3003076831
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.