Cleared Traditional

K080169 - HEARTSTRING III PROXIMAL SEAL SYSTEM

K080169 is an FDA 510(k) clearance for HEARTSTRING III PROXIMAL SEAL SYSTEM, manufactured by Guidant Corporation, Cardiac Surgery. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K080169 · Guidant Corporation, Cardiac Surgery · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
15d
Days
Class 2
Risk

K080169 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 Guidant Corporation, Cardiac Surgery (San Jose, US). The FDA issued a Cleared decision on February 8, 2008 after a review of 15 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K080169

510(k) Number K080169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2008
Decision Date February 08, 2008
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXC Clamp, Vascular

All 195
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K080169.
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MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
K080206 · Radi Medical Systems AB · Feb 2008
SIBEL SA VASCULAR CLAMP
K072834 · Surgical Instruments Belgium SA · Jan 2008
BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
K072297 · Cardiva Medical, Inc. · Sep 2007
COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE
K072167 · Advanced Vascular Dynamics · Sep 2007
K080169 · HEARTSTRING III PROXIMAL SEAL SYSTEM
Download PDF FDA Summary Guidant Corporation, …