Cleared Traditional

K790838 - ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)

K790838 is an FDA 510(k) clearance for ARTERIAL EMBOLECTOMY CATHETER (MODIFIED), 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 41-day FDA review.

K790838 · Shiley, Inc. · Cardiovascular device
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Jun 1979
Decision
41d
Days
Class 2
Risk

K790838 is an FDA 510(k) clearance for the ARTERIAL EMBOLECTOMY CATHETER (MODIFIED). Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 11, 1979 after a review of 41 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K790838

510(k) Number K790838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1979
Decision Date June 11, 1979
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
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 K790838.
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
EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE
K780762 · Shiley, Inc. · May 1978
CATHETERS, ARTERIAL EMBOLECTOMY
K780244 · Extracorporeal Medical Specialities, Inc. · Apr 1978
CATHETER, ARTERIAL EMBOLECTOMY
K770714 · Mallinckrodt Critical Care · Apr 1977