Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C) +2 more— 510(k) K261529

Name: FDA 510(k) clearance K261529
Creator: U.S. Food and Drug Administration
Published: 2026-07-06

Substantially Equivalent

Hartman Medical Group, LLC

FDA 510(k) clearance K261529 for Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C) +2 more, Substantially Equivalent on 2026-07-06. Applicant: Hartman Medical Group, LLC. Device class: 2.

Summary

Hartman Medical Group's clearance covers three kits listed by model (SIS05C, IS01, and NIS04), each under several alternate names such as Micropuncture Kit, Microintroducer Kit, and Introducer Sheath Set. They're filed under DYB, catheter introducers.

Class II, 21 CFR 870.1340. Cardiovascular is both the classification panel and the review panel, and it was a Traditional 510(k).

Hartman Medical Group filed from Birmingham, Alabama. Review took 59 calendar days (May 8 to July 6, 2026).

Clearance details

Device name as filed: 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
Product code: Product code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2026-05-08
Decision date: 2026-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, AL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYB

view all

K253526 — NAMIC Dilator and Sheath2026-07-29
K261242 — SimplGuide2026-06-25
K261950 — Health Line Tearaway Introducer2026-06-22
K261492 — FieldFlex Steerable Sheath2026-06-05
K260606 — Echo Large Bore Introducer Sheath2026-04-29

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.