HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME— 510(k) K860122

Name: FDA 510(k) clearance K860122
Creator: U.S. Food and Drug Administration
Published: 1986-04-04

Substantially Equivalent

Medical Device Consultants, Inc.

FDA 510(k) clearance K860122 for HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME, Substantially Equivalent on 1986-04-04. Applicant: Medical Device Consultants, Inc.. Device class: 2.

Clearance details

Applicant: Medical Device Consultants, Inc.
Product code: Code JBP
Device class: Class 2
Regulation: 21 CFR 864.7140
Advisory panel: Hematology
Date received: 1986-01-14
Decision date: 1986-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K860122

K-number listed on FDA's recall record

Z-0539-2026 — Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03Class II·Ongoing·Medtronic Perfusion Systems·20251020

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K860122.

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