MicroTaper Needle Introducer Set— 510(k) K151076

Name: FDA 510(k) clearance K151076
Creator: U.S. Food and Drug Administration
Published: 2015-05-22

Substantially Equivalent

Summit Access, LLC

FDA 510(k) clearance K151076 for MicroTaper Needle Introducer Set, Substantially Equivalent on 2015-05-22. Applicant: Summit Access, LLC. Device class: 2.

Clearance details

Applicant: Summit Access, LLC
Product code: Code DRE
Device class: Class 2
Regulation: 21 CFR 870.1310
Advisory panel: Cardiovascular
Date received: 2015-04-22
Decision date: 2015-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRE

view all

K261310 — FlexTract Deflectable-Rotational Dilator Sheath Set2026-07-27
K253616 — ProtekDilate Vascular Access Kit2025-12-19
K251325 — VersaCross Connect Transseptal Dilator2025-05-29
K242229 — Micro Ace Gold Advanced Micro Access System2025-01-15
K241720 — VersaCross Connect Transseptal Dilator2024-07-12

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.