Cleared Traditional

K022880 - GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500

K022880 is an FDA 510(k) clearance for GUIDANT PROXIMAL SEAL SYSTEM, manufactured by Guidant Corp.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K022880 · Guidant Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
14d
Days
Class 2
Risk

K022880 is an FDA 510(k) clearance for the GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Guidant Corp. (Lafayette, US). The FDA issued a Cleared decision on September 13, 2002 after a review of 14 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 - K022880

510(k) Number K022880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2002
Decision Date September 13, 2002
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
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

N.V. Kema

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 204
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K022880.
SMITHWICK CAROTID SHUNT
K021608 · Implantable Devices · Oct 2002
S&T SINGLE USE MICRO ANASTOMOSIS CLAMP
K022754 · S & T AG · Oct 2002
BIOVER
K011208 · Biover AG · Oct 2002
FLEXLINE CLAMP
K010727 · Novare Surgical Systems, Inc. · Aug 2002
THE HAMMER MODEL H100
K012041 · Tenacore Holdings, Inc. · Mar 2002
VCS-A SERIES CLAMP
K011863 · Vascular Control Systems, Inc. · Feb 2002
K022880 · GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
Download PDF FDA Summary Guidant Corp.