Cleared Traditional

K900311 - ARTERIAL EMBOLECTOMY CATHETER

K900311 is an FDA 510(k) clearance for ARTERIAL EMBOLECTOMY CATHETER, manufactured by Impra, Inc.. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K900311 · Impra, Inc. · Cardiovascular device
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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

FDA 510(k) Submission Details - K900311

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
Combination Product No
PCCP Authorized No
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.

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 K900311.
NEEDLE'S EYE SNARE
K961992 · Cook Pacemaker Corp. · Dec 1996
AVD INTIMAX THROMBECTOMY CATHETER
K950586 · Applied Medical Resources · May 1995
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