Cleared Traditional

K020143 - VASOVIEW 5 HARVESTING CANNULA

K020143 is an FDA 510(k) clearance for VASOVIEW 5 HARVESTING CANNULA, manufactured by Guidant Corporation, Cardiac Surgery. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K020143 · Guidant Corporation, Cardiac Surgery · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
35d
Days
Class 2
Risk

K020143 is an FDA 510(k) clearance for the VASOVIEW 5 HARVESTING CANNULA. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Guidant Corporation, Cardiac Surgery (Santa Clara, US). The FDA issued a Cleared decision on February 20, 2002 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology device 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.

View all Guidant Corporation, Cardiac Surgery devices

FDA 510(k) Submission Details - K020143

510(k) Number K020143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2002
Decision Date February 20, 2002
Days to Decision 35 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 160d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 215
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K020143.
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COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
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BALLOON CANNULA, SHORT, MODEL R65-985
K010510 · A & A Medical, Inc. · May 2001
MINI FIBER ENDOSCOPES
K003417 · Richard Wolf Medical Instruments Corp. · Apr 2001
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
K003164 · Richard Wolf Medical Instruments Corp. · Jan 2001