Cleared Traditional

K833716 - LP200 & HP800 SERIES VASCULAR PROSTH

K833716 is the FDA 510(k) clearance for LP200 & HP800 SERIES VASCULAR PROSTH by Intervascular, Inc.. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K833716 · Intervascular, Inc. · Cardiovascular device
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Jan 1984
Decision
81d
Days
Class 2
Risk

K833716 is an FDA 510(k) clearance for the LP200 & HP800 SERIES VASCULAR PROSTH. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Intervascular, Inc. (Walker, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 81 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 Intervascular, Inc. devices

Submission Details

510(k) Number K833716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1983
Decision Date January 10, 1984
Days to Decision 81 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 107
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K833716.
VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES
K853101 · Cobe Laboratories, Inc. · Feb 1986
ATRIUM PLASMA TFE SYNTHETIC ARTERY
K853725 · Atrium Medical Corp. · Dec 1985
TETRAFLEX INTEGRALLY SUPPORTED PTFE
K831822 · Shiley, Inc. · Oct 1984
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