Cleared Traditional

K864919 - SCANLAN (TM) VEIN/GRAFT HOLDER

K864919 is an FDA 510(k) clearance for SCANLAN (TM) VEIN/GRAFT HOLDER, manufactured by Scanlan Intl., Inc.. The device is a Class 2 Cardiovascular device with product code KPK cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K864919 · Scanlan Intl., Inc. · Cardiovascular device
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Jan 1987
Decision
27d
Days
Class 2
Risk

K864919 is an FDA 510(k) clearance for the SCANLAN (TM) VEIN/GRAFT HOLDER. Classified as Marker, Ostia, Aorto-saphenous Vein (product code KPK), Class II - Special Controls.

Submitted by Scanlan Intl., Inc. (Saint Paul, US). The FDA issued a Cleared decision on January 12, 1987 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4650 - 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.

FDA 510(k) Submission Details - K864919

510(k) Number K864919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1986
Decision Date January 12, 1987
Days to Decision 27 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPK Device Classification - Class 2, Special Controls

Product Code KPK Marker, Ostia, Aorto-saphenous Vein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4650
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 - KPK Marker, Ostia, Aorto-saphenous Vein

Devices cleared under the same product code (KPK) and FDA review panel - the closest regulatory comparables to K864919.
CORONARY VEIN GRAFT TAG MARKER
K971966 · Med-Edge, Inc. · Jan 1998
VOSS GRAFT MARKER
K895369 · Voss Medical Products · Sep 1989
COOK (R) VEIN GRAFT RING MARKERS
K864101 · Cook, Inc. · Oct 1986
FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.
K801637 · C.R. Bard, Inc. · Aug 1980
MARKERS, STAINLESS STEEL
K770802 · Cardio-Surgical, Inc. · Jun 1977
K864919 · SCANLAN (TM) VEIN/GRAFT HOLDER
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