Cleared Traditional

K001915 - GRAFT MARKER RING
(FDA 510(k) Clearance)

K001915 · T. Korossurgical Instruments Corp. · Cardiovascular device
Apr 2001
Decision
308d
Days
Class 2
Risk

K001915 is an FDA 510(k) clearance for the GRAFT MARKER RING. This device is classified as a Marker, Cardiopulmonary Bypass (vein Marker) (Class II - Special Controls, product code MAB).

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on April 27, 2001, 308 days after receiving the submission on June 23, 2000.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K001915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2000
Decision Date April 27, 2001
Days to Decision 308 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code MAB — Marker, Cardiopulmonary Bypass (vein Marker)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.3450