Cleared Traditional

K970762 - DUAL LUMEN EMBOLECTOMY CATHETER

K970762 is an FDA 510(k) clearance for DUAL LUMEN EMBOLECTOMY CATHETER, manufactured by Applied Medical Resources. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K970762 · Applied Medical Resources · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
25d
Days
Class 2
Risk

K970762 is an FDA 510(k) clearance for the DUAL LUMEN EMBOLECTOMY CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 25 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 Applied Medical Resources devices

FDA 510(k) Submission Details - K970762

510(k) Number K970762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1997
Decision Date March 28, 1997
Days to Decision 25 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
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 38
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K970762.
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
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LATIS GRAFT CLEANING CATHETER
K973465 · Applied Medical Resources · Feb 1998
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