Cleared Traditional

K123358 - PACIFIC PLUS

K123358 is an FDA 510(k) clearance for PACIFIC PLUS, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K123358 · Medtronic Vascular · Cardiovascular device
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Jan 2013
Decision
90d
Days
Class 2
Risk

K123358 is an FDA 510(k) clearance for the PACIFIC PLUS. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Medtronic Vascular (Santa Rosa, US). The FDA issued a Cleared decision on January 29, 2013 after a review of 90 days - within the typical 510(k) review window.

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.

View all Medtronic Vascular devices

FDA 510(k) Submission Details - K123358

510(k) Number K123358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2012
Decision Date January 29, 2013
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 345
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K123358.
SLEEK OTW PTA CATHETER
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PASSEO-35
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K123544 · Ev3, Inc. · Feb 2013
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K122984 · C.R. Bard, Inc. · Oct 2012
FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM
K122379 · Ostial Corporation · Sep 2012
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
K122070 · Trireme Medical, Inc. · Aug 2012