Cleared Traditional

K902377 - ANGEFLATOR(TM)

K902377 is an FDA 510(k) clearance for ANGEFLATOR(TM), manufactured by Angeion Corp.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K902377 · Angeion Corp. · Cardiovascular device
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Dec 1990
Decision
197d
Days
Class 2
Risk

K902377 is an FDA 510(k) clearance for the ANGEFLATOR(TM). Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Angeion Corp. (Plymouth, US). The FDA issued a Cleared decision on December 13, 1990 after a review of 197 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 Angeion Corp. devices

FDA 510(k) Submission Details - K902377

510(k) Number K902377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date December 13, 1990
Days to Decision 197 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 125d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 110
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K902377.
MEDRAD VARIBLE INFUSION INJECTOR
K905819 · Medrad, Inc. · Sep 1991
BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
K910873 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991
CLOSED SYSTEM FLUSH SET
K904994 · Argon Medical Corp. · Jan 1991
HIGH-PRESSURE CONNECTOR TUBE
K904212 · Mallinckrodt Medical · Dec 1990
MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP
K903494 · Life-Tech Intl., Inc. · Oct 1990
LIQUID DETECTOR
K903495 · Life-Tech Intl., Inc. · Oct 1990