Cleared Traditional

K170815 - PSA Cable

K170815 is an FDA 510(k) clearance for PSA Cable, manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code DTC cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K170815 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Boston Scientific Corporation devices

FDA 510(k) Submission Details - K170815

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
Combination Product No
PCCP Authorized No
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.

DTC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DTC Analyzer, Pacemaker Generator Function

All 25
Devices cleared under the same product code (DTC) and FDA review panel - the closest regulatory comparables to K170815.
PK-141 PATIENT CABLE
K083674 · Biotronik, Inc. · Apr 2009
MODEL 4810 ANALYZER OUTPUT ADAPTER
K002497 · Pace Medical · Oct 2000
EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
K961582 · North American Technical Services Corp. · Nov 1996
EXTERNAL PACEMAKER ANALYZER MODEL PMA-1
K903966 · Bio-Tek Instruments, Inc. · Jun 1991
MODEL 5311B A-V PACING SYSTEM ANALYZER
K910595 · Medtronic Vascular · May 1991
CPI MODEL 2215/SEAMED MODEL 3400
K910223 · Seamed Corp. · Mar 1991