Cleared Traditional

K831988 - INTRAVASCULAR CATHETER

K831988 is the FDA 510(k) clearance for INTRAVASCULAR CATHETER by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code FOS) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K831988 · C.R. Bard, Inc. · General Hospital
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Nov 1983
Decision
140d
Days
Class 2
Risk

K831988 is an FDA 510(k) clearance for the INTRAVASCULAR CATHETER. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on November 8, 1983 after a review of 140 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K831988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1983
Decision Date November 08, 1983
Days to Decision 140 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 129d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOS Catheter, Umbilical Artery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 General Hospital devices follow this clearance model.

Regulatory Peers - FOS Catheter, Umbilical Artery

All 13
Devices cleared under the same product code (FOS) and FDA review panel - the closest regulatory comparables to K831988.
BARD UMBILICAL VESSEL CATHETER
K890685 · C.R. Bard, Inc. · Feb 1989
ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER
K850884 · Sherwood Medical Co. · Oct 1985
XRO UMBILICAL CATHETER-CODE 270
K851005 · Vygon Corp. · May 1985
CATHETER, UMBILICAL, VICRA
K771891 · Travenol Laboratories, S.A. · Nov 1977
CATHETER, UMBILICAL ARTERY
K760966 · Sherwood Medical Industries · Jan 1977