HEART CATHETERIZATION TRAY— 510(k) K860161

Name: FDA 510(k) clearance K860161
Creator: U.S. Food and Drug Administration
Published: 1986-05-02

Substantially Equivalent

Medical Design Concepts, Inc.

FDA 510(k) clearance K860161 for HEART CATHETERIZATION TRAY, Substantially Equivalent on 1986-05-02. Applicant: Medical Design Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Medical Design Concepts, Inc.
Product code: Code DRE
Device class: Class 2
Regulation: 21 CFR 870.1310
Advisory panel: Cardiovascular
Date received: 1986-01-16
Decision date: 1986-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, 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

More clearances from Medical Design Concepts, Inc.

view all

K860160 — OPERATING ROOM TRAY1986-02-27

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.