Cleared Special

K122275 - ARTISAN EXTEND CONTROL CATHETER

K122275 is an FDA 510(k) clearance for ARTISAN EXTEND CONTROL CATHETER, manufactured by Hansen Medical. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Special 510(k) pathway after a 30-day FDA review.

K122275 · Hansen Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
30d
Days
Class 2
Risk

K122275 is an FDA 510(k) clearance for the ARTISAN EXTEND CONTROL CATHETER. Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Hansen Medical (Mountain View, US). The FDA issued a Cleared decision on August 29, 2012 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - 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.

FDA 510(k) Submission Details - K122275

510(k) Number K122275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2012
Decision Date August 29, 2012
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DRA Device Classification - Class 2, Special Controls

Product Code DRA Catheter, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1280
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 - DRA Catheter, Steerable

All 38
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K122275.
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