Cleared Traditional

K920823 - WELTER SNARE RETRIEVER

K920823 is an FDA 510(k) clearance for WELTER SNARE RETRIEVER, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K920823 · Cook, Inc. · Cardiovascular device
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Mar 1993
Decision
374d
Days
Class 2
Risk

K920823 is an FDA 510(k) clearance for the WELTER SNARE RETRIEVER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on March 4, 1993 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cook, Inc. devices

FDA 510(k) Submission Details - K920823

510(k) Number K920823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1992
Decision Date March 04, 1993
Days to Decision 374 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 125d · This submission: 374d
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 56
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K920823.
LMI OCCLUSION CATHETER
K955125 · Lucas Medical, Inc. · Mar 1996
AVD INTIMAX THROMBECTOMY CATHETER
K950586 · Applied Medical Resources · May 1995
ARTERIAL EMBOLECTOMY
K935405 · J-Lloyd Medical, Inc. · Jul 1994
INTIMAX THROMBECTOMY CATHETER
K910372 · Applied Vascular Devices, Inc. · Apr 1991
AMPLATZ GOOSE-NECK SNARE
K901502 · Microvena Corp. · Dec 1990
ARTERIAL EMBOLECTOMY CATHETER
K901627 · Applied Vascular Devices, Inc. · Oct 1990