Cleared Traditional

K923603 - INTRA-AORTIC BALLOON PUMP CATHETER - MO...

K923603 is an FDA 510(k) clearance for INTRA-AORTIC BALLOON PUMP CATHETER - MO..., manufactured by Kontron Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K923603 · Kontron Instruments, Inc. · Cardiovascular device
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Mar 1993
Decision
249d
Days
Class 2
Risk

K923603 is an FDA 510(k) clearance for the INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Everett, US). The FDA issued a Cleared decision on March 8, 1993 after a review of 249 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Kontron Instruments, Inc. devices

FDA 510(k) Submission Details - K923603

510(k) Number K923603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1992
Decision Date March 08, 1993
Days to Decision 249 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 125d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 406
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K923603.
BALT INTRODUCER
K925633 · Target Therapeutics · Jun 1993
CORDIS NIHON CATHETER SHEATH INTRODUCER
K931102 · Cordis Corp. · May 1993
ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET
K924607 · Arrow Intl., Inc. · Apr 1993
OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO
K920907 · Teleflexmedical, Inc. · Oct 1992
OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1
K920908 · Teleflexmedical, Inc. · Oct 1992
CATHETER INTRODUCER
K920528 · Boston Scientific Corp · Aug 1992