Cleared Traditional

K102532 - HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING

K102532 is an FDA 510(k) clearance for HLS CANNULA NON-COATED, manufactured by Maquet Cardiopulmonary, AG. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K102532 · Maquet Cardiopulmonary, AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
175d
Days
Class 2
Risk

K102532 is an FDA 510(k) clearance for the HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on February 25, 2011 after a review of 175 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Maquet Cardiopulmonary, AG devices

FDA 510(k) Submission Details - K102532

510(k) Number K102532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2010
Decision Date February 25, 2011
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 322
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K102532.
MEDLINE VESSEL CANNULA
K111147 · Medline Industries, Inc. · Jul 2011
CENTRIMAG RETURN CANNULA KIT
K110980 · Levitronix, LLC · Jun 2011
CENTRIMAG DRAINAGE CANNULA KIT
K110983 · Levitronix, LLC · Jun 2011
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
K102420 · Edwards Lifesciences, LLC · Oct 2010
MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L
K100274 · Medtronic, Inc. · May 2010
PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
K093730 · Edwards Lifesciences, LLC · Jan 2010