Cleared Traditional

K884065 - CATH LAB MONITORING CATHETER

K884065 is the FDA 510(k) clearance for CATH LAB MONITORING CATHETER by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K884065 · C.R. Bard, Inc. · Cardiovascular device
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Jan 1989
Decision
108d
Days
Class 2
Risk

K884065 is an FDA 510(k) clearance for the CATH LAB MONITORING CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on January 12, 1989 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K884065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1988
Decision Date January 12, 1989
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 290
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K884065.
USCI 7F GUIDE CATHETER
K890420 · C.R. Bard, Inc. · Apr 1989
IMAGER FLUSH CATHETERS
K884354 · Medi-Tech, Inc. · Apr 1989
USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
K884502 · C.R. Bard, Inc. · Jan 1989
USCI SOFT-TIP ANGIOGRAPHIC CATHETER
K883051 · C.R. Bard, Inc. · Oct 1988
SLIP-COAT(TM) CATHETERS
K882796 · Cook, Inc. · Jul 1988
TARGET THERAPEUTICS STERILE PRODUCTS
K874815 · Target Therapeutics · Feb 1988