Cleared Abbreviated

K003880 - CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)

K003880 is an FDA 510(k) clearance for CONCENTROC HD GUIDE CATHETER, manufactured by Concentric Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Abbreviated 510(k) pathway after a 152-day FDA review.

K003880 · Concentric Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
152d
Days
Class 2
Risk

K003880 is an FDA 510(k) clearance for the CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 9002.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Concentric Medical, Inc. (Moutian View, US). The FDA issued a Cleared decision on May 16, 2001 after a review of 152 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Concentric Medical, Inc. devices

FDA 510(k) Submission Details - K003880

510(k) Number K003880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2000
Decision Date May 16, 2001
Days to Decision 152 days
Submission Type Abbreviated
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
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Standards-based clearance path.

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 781
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K003880.
CORDIS M3 PTA DILATATION CATHETER
K003920 · Cordis Corp. · Jun 2001
AVIATOR PERIPHERAL DILATATION CATHETER
K010831 · Guidant Corp. · Jun 2001
CONCENTRIC RETRIEVER, MODEL 90030
K003410 · Concentric Medical, Inc. · May 2001
NUMED HIGH PRESSURE PTA CATHETERS
K010880 · NuMED, Inc. · Apr 2001
ILT DEFLECTING CATHETER, MODEL C114ND1
K010531 · Intra Luminal Therapeutics, Inc. · Apr 2001
GUIDER SOFTIP GUIDING CATHETER XF 5F
K010853 · Boston Scientific, Target · Apr 2001