Cleared Traditional

K902143 - FOGARTY VESSEL CALIBRATOR

K902143 is the FDA 510(k) clearance for FOGARTY VESSEL CALIBRATOR by Baxter Healthcare Corp. It is a Class 2 Cardiovascular device (product code DWP) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K902143 · Baxter Healthcare Corp · Cardiovascular device
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Oct 1990
Decision
154d
Days
Class 2
Risk

K902143 is an FDA 510(k) clearance for the FOGARTY VESSEL CALIBRATOR. Classified as Dilator, Vessel, Surgical (product code DWP), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on October 16, 1990 after a review of 154 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4475 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K902143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1990
Decision Date October 16, 1990
Days to Decision 154 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
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWP Dilator, Vessel, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4475
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 - DWP Dilator, Vessel, Surgical

All 9
Devices cleared under the same product code (DWP) and FDA review panel - the closest regulatory comparables to K902143.
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
K220981 · Fehling Surgical Instruments, Inc. · Apr 2023
Geomed Vascular Dilators
K183438 · Geomed Medizin-Technik GmbH & Co. · Sep 2019
LAPAROSCOPIC VESSEL ARTICULATOR
K911475 · United States Endoscopy Group, Inc. · Jul 1991
VESSEL DILATOR
K832595 · Abbott Laboratories · Aug 1983
REUSABLE FOGARTY FLEXIBLE CALIBRATOR
K822687 · American Edwards Laboratories · Oct 1982
FOGARTY FLEXIBLE PROBE
K812935 · American Edwards Laboratories · Nov 1981