Cleared Traditional

K001915 - GRAFT MARKER RING

K001915 is an FDA 510(k) clearance for GRAFT MARKER RING, manufactured by T. Korossurgical Instruments Corp.. The device is a Class 2 Cardiovascular device with product code MAB cleared through the Traditional 510(k) pathway after a 308-day FDA review.

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

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

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on April 27, 2001 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all T. Korossurgical Instruments Corp. devices

FDA 510(k) Submission Details - K001915

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 125d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAB Device Classification - Class 2, Special Controls

Product Code MAB Marker, Cardiopulmonary Bypass (vein Marker)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.