Cleared Traditional

K150107 - Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter

K150107 is an FDA 510(k) clearance for Arc Intracranial Support Catheter, manufactured by Micro Therapeutics Inc Dba Ev3 Neurovascular. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K150107 · Micro Therapeutics Inc Dba Ev3 Neurovascular · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
190d
Days
Class 2
Risk

K150107 is an FDA 510(k) clearance for the Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Micro Therapeutics Inc Dba Ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on July 29, 2015 after a review of 190 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 - K150107

510(k) Number K150107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2015
Decision Date July 29, 2015
Days to Decision 190 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
65d slower than avg
Panel avg: 125d · This submission: 190d
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 855
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K150107.
Selectra Catheters and Selectra Accessory Kit
K151409 · Biotronik, Inc. · Aug 2015
Wingman Crossing Catheter
K151880 · Reflow Medical · Aug 2015
Metacross RX PTA Balloon Dilitation Catheter
K150865 · KANEKA Corporation · Aug 2015
ASAHI Corsair Microcatheter
K151103 · Asahi Intecc Co., Ltd. · Jun 2015
MicroCross Catheter
K151082 · Roxwood Medical, Inc. · Jun 2015
Coda LP Balloon Catheter
K150970 · Cook Incorporated · May 2015