Cleared Traditional

K170815 - PSA Cable (FDA 510(k) Clearance)

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

K170815 · Boston Scientific Corporation · Cardiovascular device
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Jul 2017
Decision
111d
Days
Class 2
Risk

K170815 is an FDA 510(k) clearance for the PSA Cable. Classified as Analyzer, Pacemaker Generator Function (product code DTC), Class II - Special Controls.

Submitted by Boston Scientific Corporation (St Paul, US). The FDA issued a Cleared decision on July 6, 2017 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3630 - 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.

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Submission Details

510(k) Number K170815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2017
Decision Date July 06, 2017
Days to Decision 111 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
14d faster than avg
Panel avg: 125d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTC Analyzer, Pacemaker Generator Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3630
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.