Cleared Traditional

K902143 - FOGARTY VESSEL CALIBRATOR

K902143 is an FDA 510(k) clearance for FOGARTY VESSEL CALIBRATOR, manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K902143

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.

DWP Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (DWP) and FDA review panel - the closest regulatory comparables to K902143.
LAPAROSCOPIC VESSEL ARTICULATOR
K911475 · United States Endoscopy Group, Inc. · Jul 1991
ROBICSEK PROBE/RETRACTOR
K910682 · Bio-Vascular, Inc. · May 1991
FLO-RESTER(R) VESSEL SIZER
K905159 · Bio-Vascular, Inc. · Feb 1991
PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)
K891786 · Pioneering Technologies, Inc. · Oct 1989
VESSEL DILATOR
K832595 · Abbott Laboratories · Aug 1983
REUSABLE FOGARTY FLEXIBLE CALIBRATOR
K822687 · American Edwards Laboratories · Oct 1982