Cleared Traditional

K081986 - SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE

K081986 is an FDA 510(k) clearance for SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE, 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 123-day FDA review.

K081986 · Oscor, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
123d
Days
Class 2
Risk

K081986 is an FDA 510(k) clearance for the SAFESEPT 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 November 14, 2008 after a review of 123 days - within the typical 510(k) review window.

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 - K081986

510(k) Number K081986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2008
Decision Date November 14, 2008
Days to Decision 123 days
Submission Type Traditional
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
2d faster than avg
Panel avg: 125d · This submission: 123d
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 K081986.
Needle Free Transseptal Cannula
K172934 · Pressure Products Medical Device Manufacturing, LLC · Feb 2018
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE
K130843 · Oscor, Inc. · Jan 2014
BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
K122587 · St Jude Medical · Feb 2013
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