Cleared Traditional

K130843 - SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR...

K130843 is an FDA 510(k) clearance for SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR..., manufactured by Oscor, Inc.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K130843 · Oscor, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
287d
Days
Class 2
Risk

K130843 is an FDA 510(k) clearance for the SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on January 8, 2014 after a review of 287 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 Oscor, Inc. devices

FDA 510(k) Submission Details - K130843

510(k) Number K130843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2013
Decision Date January 08, 2014
Days to Decision 287 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 125d · This submission: 287d
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 34
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K130843.
SafeSept Blunt Needle
K210328 · Pressure Products Medical Device Manufacturing, LLC · Mar 2021
TSN Transseptal Needle
K172950 · Pressure Products Medical Device Manufacturing, LLC · Feb 2018
Needle Free Transseptal Cannula
K172934 · Pressure Products Medical Device Manufacturing, LLC · Feb 2018
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