Cleared Special

K121265 - AMPHIRION PLUS PTA CATHETER

K121265 is an FDA 510(k) clearance for AMPHIRION PLUS PTA CATHETER, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 26-day FDA review.

K121265 · Medtronic, Inc. · Cardiovascular device
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May 2012
Decision
26d
Days
Class 2
Risk

K121265 is an FDA 510(k) clearance for the AMPHIRION PLUS PTA CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Medtronic, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on May 22, 2012 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic, Inc. devices

FDA 510(k) Submission Details - K121265

510(k) Number K121265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2012
Decision Date May 22, 2012
Days to Decision 26 days
Submission Type Special
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
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 290
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K121265.
PACIFIC PLUS
K123358 · Medtronic Vascular · Jan 2013
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K122984 · C.R. Bard, Inc. · Oct 2012
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K112797 · Cordis Corp. · May 2012
RIVAL PTA DILATATION CATHETER
K120722 · Bard Peripheral Vascular, Inc. · Apr 2012
ATLAS PTA BALLOON DILATATION CATHETER
K120971 · Bard Peripheral Vascular, Inc. · Apr 2012