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)
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.

View all St Jude Medical devices

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 41
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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K122832 · Great Batch Medical · Dec 2012
MOBICATH TRANSSEPTAL NEEDLE
K111644 · Great Batch Medical · Oct 2011
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
K081986 · Oscor, Inc. · Nov 2008