Cleared Traditional

K882314 - CORONARY VEIN GRAFT MARKER

K882314 is an FDA 510(k) clearance for CORONARY VEIN GRAFT MARKER, manufactured by Med-Edge, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K882314 · Med-Edge, Inc. · Cardiovascular device
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Aug 1988
Decision
62d
Days
Class 2
Risk

K882314 is an FDA 510(k) clearance for the CORONARY VEIN GRAFT MARKER. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Med-Edge, Inc. (Clemmons, US). The FDA issued a Cleared decision on August 4, 1988 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Med-Edge, Inc. devices

FDA 510(k) Submission Details - K882314

510(k) Number K882314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1988
Decision Date August 04, 1988
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSY Device Classification - Class 2, Special Controls

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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.

Regulatory Peers - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 153
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K882314.
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
K893459 · Medtronic Vascular · Sep 1989
TORAY VASCULAR PROSTHESIS
K884083 · Toray Industries (America), Inc. · Jan 1989
ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.
K882289 · Aries Medical, Inc. · Dec 1988
MEADOX INTRA-AORTIC GRAFT
K881283 · Meadox Medicals, Div. Boston Scientific Corp. · May 1988
GORE-TEX VASCULAR GRAFT
K880167 · W.L. Gore & Associates, Inc. · May 1988
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
K871110 · Edward Weck, Inc. · Aug 1987