Cleared Traditional

ARTERIAL EMBOLECTOMY CATHETER (K900311) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900311 · Impra, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
176d
Days
Class 2
Risk

K900311 is an FDA 510(k) clearance for the ARTERIAL EMBOLECTOMY CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Impra, Inc. (Tempe, US). The FDA issued a Cleared decision on July 17, 1990 after a review of 176 days - an extended review 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: 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 Impra, Inc. devices

Submission Details

510(k) Number K900311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1990
Decision Date July 17, 1990
Days to Decision 176 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 125d · This submission: 176d
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 21
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K900311.
MEDTRONIC EXPORT AP CATHETER
K081573 · Medtronic Vascular · Jun 2008
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
K982141 · Arrow Intl., Inc. · Aug 1998
WELTER SNARE RETRIEVER
K920823 · Cook, Inc. · Mar 1993
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
K901625 · Baxter Healthcare Corp · Jul 1990
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
K894681 · Shiley, Inc. · Oct 1989
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
K892410 · Baxter Healthcare Corp · Jul 1989