Cleared Traditional

K130382 - HEARTSTRING III PROXIMAL SEAL SYSTEM

K130382 is an FDA 510(k) clearance for HEARTSTRING III PROXIMAL SEAL SYSTEM, manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K130382 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
111d
Days
Class 2
Risk

K130382 is an FDA 510(k) clearance for the HEARTSTRING III PROXIMAL SEAL SYSTEM. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Wayne, US). The FDA issued a Cleared decision on June 5, 2013 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 870.4450 - 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 - K130382

510(k) Number K130382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2013
Decision Date June 05, 2013
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.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 154
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K130382.
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