Cleared Special

K031922 - CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W

K031922 is an FDA 510(k) clearance for CAPTIVA BLOOD CONTAINMENT DEVICE CN100, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 100-day FDA review.

K031922 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
100d
Days
Class 2
Risk

K031922 is an FDA 510(k) clearance for the CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 1, 2003 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031922

510(k) Number K031922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2003
Decision Date October 01, 2003
Days to Decision 100 days
Submission Type Special
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
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

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 705
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K031922.
INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER
K033527 · B.Braun Medical, Inc. · Feb 2004
MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
K034061 · Boston Scientific Corp · Jan 2004
GLIDESHEATH
K033681 · Terumo Corp. · Dec 2003
SHORT INTRODUCER SHEATH
K032569 · Rex Medical · Sep 2003
PATHWAY ACCESS SHEATH CATHETER
K030734 · Vertelink Corporation · Sep 2003
SELDINGER SAFETY NEEDLE INTRODUCER
K032404 · Hdc Corp. · Sep 2003
K031922 · CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
Download PDF FDA Summary Merit Medical Systems…