Cleared Traditional

K832044 - SHILEY MULTIPRO CATHETER

K832044 is an FDA 510(k) clearance for SHILEY MULTIPRO CATHETER, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K832044 · Shiley, Inc. · Cardiovascular device
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Sep 1983
Decision
97d
Days
Class 2
Risk

K832044 is an FDA 510(k) clearance for the SHILEY MULTIPRO CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K832044

510(k) Number K832044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1983
Decision Date September 29, 1983
Days to Decision 97 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
28d faster than avg
Panel avg: 125d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXE Device Classification - Class 2, Special Controls

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - DXE Catheter, Embolectomy

All 36
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K832044.
SHEAR FORCE GAUGE
K864330 · American Edwards Laboratories · Jan 1987
EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER
K864007 · Uresil Corp. · Jan 1987
ARTERIAL EMBOLECTOMY CATHETER
K840198 · Shiley, Inc. · Aug 1984
ATRAC TM MULTIPURPOSE BALLOON CATHETER
K820646 · Atrium Medical Corp. · Mar 1982
URE SIL EMBOLECTOMY/THROMBECTOMY CATH
K812640 · Uresil Corp. · Oct 1981
ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)
K790838 · Shiley, Inc. · Jun 1979