Cleared Traditional

K962978 - CCENTERMARK CATHETER INTRODUCER SHEALTH...

K962978 is the FDA 510(k) clearance for CCENTERMARK CATHETER INTRODUCER SHEALTH... by Johnson & Johnson Medical, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K962978 · Johnson & Johnson Medical, Inc. · Cardiovascular device
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Jan 1997
Decision
160d
Days
Class 2
Risk

K962978 is an FDA 510(k) clearance for the CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Johnson & Johnson Medical, Inc. (Menlo Park, US). The FDA issued a Cleared decision on January 7, 1997 after a review of 160 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 Johnson & Johnson Medical, Inc. devices

Submission Details

510(k) Number K962978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1996
Decision Date January 07, 1997
Days to Decision 160 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
35d slower than avg
Panel avg: 125d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 391
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K962978.
FAST-CATH TRANSSEPTAL CATHETER INTRODUCER
K964518 · Daig Corp. · May 1997
TRANSJUGULAR ACCESS SET
K964034 · AngioDynamics, Inc. · May 1997
EVS
K963886 · Applied Medical Resources · Apr 1997
CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT
K962746 · Cordis Corp. · Oct 1996
BRAUN PERCUTANEOUS INTRODUCER SET
K961745 · B.Braun Medical, Inc. · Sep 1996
INPUT TUOHY-BORST LOCKING DEVICE
K960445 · C.R. Bard, Inc. · Aug 1996