Cleared Traditional

SafeSept Transseptal Guidewire (K170671) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170671 · Pressure Products Medical Device Manufacturing, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
228d
Days
Class 2
Risk

K170671 is an FDA 510(k) clearance for the SafeSept Transseptal Guidewire. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Pressure Products Medical Device Manufacturing, LLC (Morton, US). The FDA issued a Cleared decision on October 20, 2017 after a review of 228 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 Pressure Products Medical Device Manufacturing, LLC devices

Submission Details

510(k) Number K170671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2017
Decision Date October 20, 2017
Days to Decision 228 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
103d slower than avg
Panel avg: 125d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 15
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K170671.
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
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