Cleared Traditional

K011783 - MULTI-SNARE SET

K011783 is an FDA 510(k) clearance for MULTI-SNARE SET, manufactured by Pfm Produkte Fur Die Medizin AG. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K011783 · Pfm Produkte Fur Die Medizin AG · Cardiovascular device
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Jan 2002
Decision
231d
Days
Class 2
Risk

K011783 is an FDA 510(k) clearance for the MULTI-SNARE SET. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Pfm Produkte Fur Die Medizin AG (Trabuco Canyon, US). The FDA issued a Cleared decision on January 24, 2002 after a review of 231 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 Pfm Produkte Fur Die Medizin AG devices

FDA 510(k) Submission Details - K011783

510(k) Number K011783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2001
Decision Date January 24, 2002
Days to Decision 231 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 125d · This submission: 231d
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 57
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K011783.
MEDTRONIC EXPORT AP CATHETER
K081573 · Medtronic Vascular · Jun 2008
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
K022145 · LeMaitre Vascular, Inc. · Jan 2003
MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K020634 · Atrium Medical Corp. · May 2002
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K002627 · Atrium Medical Corp. · Apr 2001
LEMAITRE IRRIGATION CATHETER
K992933 · Vascutech, Inc. · Mar 2000
LEMAITRE VENOUS THROMBECTOMY CATHETER
K992934 · Vascutech, Inc. · Mar 2000