Cleared Traditional

K971314 - DCAT EMBOLECTOMY CATHETER SYSTEM

K971314 is an FDA 510(k) clearance for DCAT EMBOLECTOMY CATHETER SYSTEM, manufactured by AngioDynamics, Inc.. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K971314 · AngioDynamics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
342d
Days
Class 2
Risk

K971314 is an FDA 510(k) clearance for the DCAT EMBOLECTOMY CATHETER SYSTEM. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on March 17, 1998 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 AngioDynamics, Inc. devices

FDA 510(k) Submission Details - K971314

510(k) Number K971314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1997
Decision Date March 17, 1998
Days to Decision 342 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 125d · This submission: 342d
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 K971314.
LEMAITRE EMBOLECTOMY CATHETER
K992368 · Vascutech, Inc. · Dec 1999
BIOSENSORS EMBOLECTOMY CATHETER
K973477 · Sunscope Intl., Inc. · Sep 1998
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
K982141 · Arrow Intl., Inc. · Aug 1998
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