Cleared Traditional

K801650 - DESERET EMBOLECTOMY/THROMBECTOMY CATH.

K801650 is the FDA 510(k) clearance for DESERET EMBOLECTOMY/THROMBECTOMY CATH. by Deseret Medical, Inc.. It is a Class 2 Cardiovascular device (product code DXE) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K801650 · Deseret Medical, Inc. · Cardiovascular device
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Aug 1980
Decision
17d
Days
Class 2
Risk

K801650 is an FDA 510(k) clearance for the DESERET EMBOLECTOMY/THROMBECTOMY CATH.. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Deseret Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1980 after a review of 17 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Deseret Medical, Inc. devices

Submission Details

510(k) Number K801650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1980
Decision Date August 04, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K801650.
SHILEY MULTIPRO CATHETER
K832044 · Shiley, Inc. · Sep 1983
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
EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE
K780762 · Shiley, Inc. · May 1978
CATHETERS, ARTERIAL EMBOLECTOMY
K780244 · Extracorporeal Medical Specialities, Inc. · Apr 1978