K261529
- 510(k) number
- K261529
- Device name
- Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)
- Applicant
- Hartman Medical Group, LLC AL · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2026-07-06
- Date received
- 2026-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K261529.pdf
Official FDA record: K261529
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.