Vaculink, Model VCL 3000

FDA 510(k) K043614 · Medevco, Inc.

Substantially Equivalent

510(k) numberK043614

Submission

Device name
Vaculink, Model VCL 3000
Applicant
Medevco, Inc.
Plano, TX, US
Received
December 30, 2004
Decision date
April 14, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HDB – Extractor, Vacuum, Fetal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4340
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HDB

510(k)DeviceApplicantDecision
K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum…HDB · Traditional Clinical Innovations, LLC10/08/2025SE
K041579Medela Single Use Silc Cup, Model 077.0791HDB · Traditional Medela AG04/21/2005SE
K021193Fortune Silicone Vacuum Suction, Model #1300HDB · Traditional Fortune Medical Instrument Corp.02/12/2003SE
K020447Mityvac Merlin, Model 10027HDB · Special Prism Enterprises, Inc.04/12/2002SE
K013460Swift Low Profile Cup (Pro Cup)HDB · Traditional Swift Delivery Products01/17/2002SE
K011532MityvacHDB · Special Prism Enterprises, Inc.07/30/2001SE
K981260Kiwi Soft Cup with Palm Pump Model Number VFE-6000S, Kiwi Mushroom Cup with Palm Pump…HDB · Traditional Clinical Innovations, Inc.09/22/1998SE
K980976Ameda Disposable Vacuum Assist Cup with Fluid Retention TrapHDB · Traditional Hollister, Inc.08/21/1998SE
K980212MityvacHDB · Traditional Prism Technologies, Inc.07/09/1998SE
K973942Swift Delivery Product #300HDB · Traditional Swift Delivery Products12/12/1997SE

Questions and answers

When was Vaculink, Model VCL 3000 cleared by the FDA?

Vaculink, Model VCL 3000 (K043614) received a 510(k) decision of Substantially Equivalent on April 14, 2005, 105 days after the submission was received.

What is the product code of K043614?

The FDA product code is HDB – Extractor, Vacuum, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.4340.