Cleared Traditional

K955588 - VASCUTEK GRAFT SIZER SET

K955588 is an FDA 510(k) clearance for VASCUTEK GRAFT SIZER SET, manufactured by Carbomedics, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K955588 · Carbomedics, Inc. · Cardiovascular device
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Mar 1996
Decision
91d
Days
Class 2
Risk

K955588 is an FDA 510(k) clearance for the VASCUTEK GRAFT SIZER SET. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Carbomedics, Inc. (Austin, US). The FDA issued a Cleared decision on March 7, 1996 after a review of 91 days - within the typical 510(k) review window.

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 Carbomedics, Inc. devices

FDA 510(k) Submission Details - K955588

510(k) Number K955588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received December 07, 1995
Decision Date March 07, 1996
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
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 128
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K955588.
MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT
K955460 · Meadox Medicals, Div. Boston Scientific Corp. · May 1996
VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT
K960706 · Carbomedics, Inc. · Apr 1996
DIASTAT VASCULAR ACCESS GRAFT
K955532 · W.L. Gore & Associates, Inc. · Mar 1996
VASCUTEK GELSOFT PLUS VASCULAR GRAFT
K955230 · Vascutek, Ltd. · Feb 1996
VASCUTEK GELWEAVE VASCULAR GRAFT
K952293 · Vascutek, Ltd. · Dec 1995
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
K954582 · C.R. Bard, Inc. · Dec 1995