Cleared Traditional

K853101 - VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES

K853101 is an FDA 510(k) clearance for VASCUTER EXTERNAL REINFORCE TRIAXIAL PR..., manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K853101 · Cobe Laboratories, Inc. · Cardiovascular device
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Feb 1986
Decision
216d
Days
Class 2
Risk

K853101 is an FDA 510(k) clearance for the VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on February 24, 1986 after a review of 216 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Cobe Laboratories, Inc. devices

FDA 510(k) Submission Details - K853101

510(k) Number K853101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date February 24, 1986
Days to Decision 216 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
91d slower than avg
Panel avg: 125d · This submission: 216d
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 133
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K853101.
VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN
K861808 · Cobe Laboratories, Inc. · Sep 1986
MEADOS INTRAORTIC GRAFT
K841596 · Meadox Medicals, Div. Boston Scientific Corp. · May 1986
MEADOX MEDICALS INC. GRAFT SIZER
K854431 · Meadox Medicals, Div. Boston Scientific Corp. · May 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