Cleared Special

K122587 - BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208

K122587 is an FDA 510(k) clearance for BRK TRANSSEPTAL NEEDLE MODEL 407200, manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Special 510(k) pathway after a 167-day FDA review.

K122587 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
167d
Days
Class 2
Risk

K122587 is an FDA 510(k) clearance for the BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by St Jude Medical (Minnetonka, US). The FDA issued a Cleared decision on February 7, 2013 after a review of 167 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - 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. Standard predicate reliance. 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 - K122587

510(k) Number K122587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2012
Decision Date February 07, 2013
Days to Decision 167 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
42d slower than avg
Panel avg: 125d · This submission: 167d
Pathway characteristics
Modification to existing cleared device.

DRC Device Classification - Class 2, Special Controls

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 - DRC Trocar

All 50
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K122587.
SafeSept Transseptal Guidewire
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K132943 · Synaptic Medical Limited · Aug 2014
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE
K130843 · Oscor, Inc. · Jan 2014
MOBICATH TRANSSEPTAL NEEDLE
K122832 · Great Batch Medical · Dec 2012
MOBICATH TRANSSEPTAL NEEDLE
K111644 · Great Batch Medical · Oct 2011
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
K081986 · Oscor, Inc. · Nov 2008
K122587 · BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
Download PDF FDA Summary St Jude Medical