Cleared Traditional

K972572 - SINGLE LUMEN EMBOLECTOMY CATHETER

K972572 is an FDA 510(k) clearance for SINGLE LUMEN EMBOLECTOMY CATHETER, manufactured by American Biomed, Inc.. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K972572 · American Biomed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
187d
Days
Class 2
Risk

K972572 is an FDA 510(k) clearance for the SINGLE LUMEN EMBOLECTOMY CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by American Biomed, Inc. (Houston, US). The FDA issued a Cleared decision on January 13, 1998 after a review of 187 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 American Biomed, Inc. devices

FDA 510(k) Submission Details - K972572

510(k) Number K972572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1997
Decision Date January 13, 1998
Days to Decision 187 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
62d slower than avg
Panel avg: 125d · This submission: 187d
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 56
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K972572.
AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
K972511 · Microvena Corp. · Mar 1998
LATIS GRAFT CLEANING CATHETER
K973465 · Applied Medical Resources · Feb 1998
EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
K974335 · J-Lloyd Medical, Inc. · Feb 1998
LMI IRRIGATION CATHETER (IGR)
K972623 · Lucas Medical, Inc. · Nov 1997
LMI THROMBECTOMY CATHETER
K970657 · Lucas Medical, Inc. · Jul 1997
DUAL LUMEN EMBOLECTOMY CATHETER
K970762 · Applied Medical Resources · Mar 1997