Cleared Traditional

K893459 - PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)

K893459 is an FDA 510(k) clearance for PLASMA TFE VASCULAR PROSTHESIS (ALTER. ..., manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K893459 · Medtronic Vascular · Cardiovascular device
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Sep 1989
Decision
140d
Days
Class 2
Risk

K893459 is an FDA 510(k) clearance for the PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE). Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on September 20, 1989 after a review of 140 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K893459

510(k) Number K893459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1989
Decision Date September 20, 1989
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
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 152
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K893459.
PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS
K901682 · Pioneering Technologies, Inc. · Jul 1990
PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
K896964 · Medtronic Vascular · Jun 1990
VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)
K894732 · Medtronic Vascular · Oct 1989
TORAY VASCULAR PROSTHESIS
K884083 · Toray Industries (America), Inc. · Jan 1989
ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.
K882289 · Aries Medical, Inc. · Dec 1988
MEADOX INTRA-AORTIC GRAFT
K881283 · Meadox Medicals, Div. Boston Scientific Corp. · May 1988