Cleared Traditional

K924607 - ARROW FISCHELL KINK RESIST PERCUT SHEAT...

K924607 is an FDA 510(k) clearance for ARROW FISCHELL KINK RESIST PERCUT SHEAT..., manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K924607 · Arrow Intl., Inc. · Cardiovascular device
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Apr 1993
Decision
223d
Days
Class 2
Risk

K924607 is an FDA 510(k) clearance for the ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on April 22, 1993 after a review of 223 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K924607

510(k) Number K924607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1992
Decision Date April 22, 1993
Days to Decision 223 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 125d · This submission: 223d
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 408
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K924607.
ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET
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INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION
K923603 · Kontron Instruments, Inc. · Mar 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