Cleared Traditional

K831822 - TETRAFLEX INTEGRALLY SUPPORTED PTFE

K831822 is an FDA 510(k) clearance for TETRAFLEX INTEGRALLY SUPPORTED PTFE, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 497-day FDA review.

K831822 · Shiley, Inc. · Cardiovascular device
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Oct 1984
Decision
497d
Days
Class 2
Risk

K831822 is an FDA 510(k) clearance for the TETRAFLEX INTEGRALLY SUPPORTED PTFE. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Shiley, Inc. (Walker, US). The FDA issued a Cleared decision on October 16, 1984 after a review of 497 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Shiley, Inc. devices

FDA 510(k) Submission Details - K831822

510(k) Number K831822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1983
Decision Date October 16, 1984
Days to Decision 497 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
372d slower than avg
Panel avg: 125d · This submission: 497d
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 125
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K831822.
MEADOX MEDICALS INC. GRAFT SIZER
K854431 · Meadox Medicals, Div. Boston Scientific Corp. · May 1986
VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES
K853101 · Cobe Laboratories, Inc. · Feb 1986
ATRIUM PLASMA TFE SYNTHETIC ARTERY
K853725 · Atrium Medical Corp. · Dec 1985
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