Cleared Special

K221707 - SafeSept® Transseptal Guidewire (SS-140) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221707 · Pressure Products Medical Device Manufacturing, LLC · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2022
Decision
93d
Days
Class 2
Risk

K221707 is an FDA 510(k) clearance for the SafeSept® Transseptal Guidewire (SS-140). 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 September 14, 2022 after a review of 93 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. 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 Pressure Products Medical Device Manufacturing, LLC devices

Submission Details

510(k) Number K221707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2022
Decision Date September 14, 2022
Days to Decision 93 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

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.