Cleared Traditional

K061070 - HANSEN MEDICAL TRANSSEPTAL NEEDLE AND D...

K061070 is an FDA 510(k) clearance for HANSEN MEDICAL TRANSSEPTAL NEEDLE AND D..., manufactured by Hansen Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K061070 · Hansen Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
179d
Days
Class 2
Risk

K061070 is an FDA 510(k) clearance for the HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Hansen Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 13, 2006 after a review of 179 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. 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 Hansen Medical, Inc. devices

FDA 510(k) Submission Details - K061070

510(k) Number K061070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2006
Decision Date October 13, 2006
Days to Decision 179 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 125d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 35
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K061070.
BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
K122587 · St Jude Medical · Feb 2013
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
K081986 · Oscor, Inc. · Nov 2008
BRK TRANSSEPTAL NEEDLE
K072278 · St Jude Medical · Sep 2007
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5
K022117 · Merit Medical Systems, Inc. · Oct 2002
TRANSSEPTAL NEEDLE/TROCAR
K011727 · Thomas Medical Products, Inc. · May 2002
MANAN POTTS-COURNAND NEEDLE
K974742 · Medical Device Technologies, Inc. · Apr 1998