Cleared Traditional

K141529 - ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER

K141529 is an FDA 510(k) clearance for ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLO..., manufactured by Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K141529 · Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
177d
Days
Class 2
Risk

K141529 is an FDA 510(k) clearance for the ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S (Sunnyvale, US). The FDA issued a Cleared decision on December 3, 2014 after a review of 177 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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.

FDA 510(k) Submission Details - K141529

510(k) Number K141529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2014
Decision Date December 03, 2014
Days to Decision 177 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
52d slower than avg
Panel avg: 125d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 861
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K141529.
ADROIT Guiding Catheter
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CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter
K142235 · St Jude Medical · Dec 2014
CPS Direct MediGuide Enabled outer catheter
K142239 · St Jude Medical · Dec 2014
TURNPIKE CATHETER
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CENTERCROSS CATHETER
K140910 · Roxwood Medical, Inc. · Nov 2014
Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter
K142565 · Stryker Neurovascular · Nov 2014
K141529 · ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER
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