Cleared Traditional

K853625 - NOVA ARTERIAL EMBOLECTOMY CATHETER

K853625 is an FDA 510(k) clearance for NOVA ARTERIAL EMBOLECTOMY CATHETER, manufactured by Nova Medical Specialties. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K853625 · Nova Medical Specialties · Cardiovascular device
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Jan 1986
Decision
139d
Days
Class 2
Risk

K853625 is an FDA 510(k) clearance for the NOVA ARTERIAL EMBOLECTOMY CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Nova Medical Specialties (Indian Mills, US). The FDA issued a Cleared decision on January 15, 1986 after a review of 139 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 Nova Medical Specialties devices

FDA 510(k) Submission Details - K853625

510(k) Number K853625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1985
Decision Date January 15, 1986
Days to Decision 139 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 125d · This submission: 139d
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 59
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K853625.
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
K892410 · Baxter Healthcare Corp · Jul 1989
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
SHILEY MULTIPRO CATHETER
K832044 · Shiley, Inc. · Sep 1983
ATRAC TM MULTIPURPOSE BALLOON CATHETER
K820646 · Atrium Medical Corp. · Mar 1982