Cleared Traditional

K830016 - VASCUTEK VASCULAR PROTHESIS VP1200K/50K

K830016 is the FDA 510(k) clearance for VASCUTEK VASCULAR PROTHESIS VP1200K/50K by Pacesetter Systems. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K830016 · Pacesetter Systems · Cardiovascular device
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Dec 1983
Decision
352d
Days
Class 2
Risk

K830016 is an FDA 510(k) clearance for the VASCUTEK VASCULAR PROTHESIS VP1200K/50K. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Pacesetter Systems (Walker, US). The FDA issued a Cleared decision on December 21, 1983 after a review of 352 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 Pacesetter Systems devices

Submission Details

510(k) Number K830016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1983
Decision Date December 21, 1983
Days to Decision 352 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
227d slower than avg
Panel avg: 125d · This submission: 352d
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 96
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K830016.
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
IONESCU-SHILEY LOW POROSITY COMPOSITE
K831865 · Shiley, Inc. · Oct 1983
IONESCU-SHILEY LOW POROSITY AORTIC GRAFT
K831880 · Shiley, Inc. · Oct 1983
MICROVEL DOUBLE VELOUR SUPPORTED 100
K822633 · Meadox Medicals, Div. Boston Scientific Corp. · Jul 1983