Pilling Weck Surgical Heart Stabilizer Removable Pads

FDA 510(k) K992476 · Pilling Weck Surgical

Substantially Equivalent

510(k) numberK992476

Submission

Device name
Pilling Weck Surgical Heart Stabilizer Removable Pads
Applicant
Pilling Weck Surgical
Fort Washington, PA, US
Received
July 26, 1999
Decision date
September 13, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MWS – Stabilizer, Heart
Device class
Class I (low risk)
Regulation
21 CFR 870.4500
Specialty
Cardiovascular

Other 510(k)s with product code MWS

510(k)DeviceApplicantDecision
K041338Medtronic Octopus Te Stabilizer & AccessoriesMWS · Traditional Medtronic Vascular07/19/2004SE
K992833Vacuum Assist StabilizerMWS · Traditional Cardio Thoracic Systems11/10/1999SE
K982419Heart-Lift Balloon PositionerMWS · Traditional Cardiothoracic Systems, Inc.01/13/1999SE

More from Cardiothoracic Systems, Inc.

510(k)DeviceDecision
K992174Pilling Weck Surgical Aortic Spoon-Jaw ClampDXC · Traditional 03/23/2000SE
K990935Jackson Esophageal DilatorKNQ · Traditional 05/17/1999SE
K990561Optical ForcepsJEK · Traditional 05/14/1999SE
K982128Shikani-French Speaking ValveJOH · Traditional 10/23/1998SE

Questions and answers

When was Pilling Weck Surgical Heart Stabilizer Removable Pads cleared by the FDA?

Pilling Weck Surgical Heart Stabilizer Removable Pads (K992476) received a 510(k) decision of Substantially Equivalent on September 13, 2000, 415 days after the submission was received.

What is the product code of K992476?

The FDA product code is MWS – Stabilizer, Heart, a Class I (low risk) device regulated under 21 CFR 870.4500.