Cleared Traditional

K832806 - CORONARY ANASTOMOSIS MARKING SYSTEM

K832806 is an FDA 510(k) clearance for CORONARY ANASTOMOSIS MARKING SYSTEM, manufactured by Biotrac Laboratories. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K832806 · Biotrac Laboratories · Cardiovascular device
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Sep 1983
Decision
42d
Days
Class 2
Risk

K832806 is an FDA 510(k) clearance for the CORONARY ANASTOMOSIS MARKING SYSTEM. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Biotrac Laboratories (Walker, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 42 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 Biotrac Laboratories devices

FDA 510(k) Submission Details - K832806

510(k) Number K832806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date September 29, 1983
Days to Decision 42 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 125d · This submission: 42d
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 164
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K832806.
VASCUTEK VASCULAR PROTHESIS VP1200K/50K
K830016 · Pacesetter Systems · Dec 1983
IONESCU-SHILEY LOW POROSITY COMPOSITE
K831865 · Shiley, Inc. · Oct 1983
IONESCU-SHILEY LOW POROSITY AORTIC GRAFT
K831880 · Shiley, Inc. · Oct 1983
VASCULAR GRAFT PROSTHESIS EXPANDED MICR
K830543 · Impra, Inc. · Jul 1983
MICROVEL DOUBLE VELOUR SUPPORTED 100
K822633 · Meadox Medicals, Div. Boston Scientific Corp. · Jul 1983
BARD PTFE VASCULAR PROSTHESIS
K821716 · C.R. Bard, Inc. · Aug 1982