Suturing Washer

FDA 510(k) K052642 · First Call, Inc.

Substantially Equivalent

510(k) numberK052642

Submission

Device name
Suturing Washer
Applicant
First Call, Inc.
Derby, CT, US
Received
September 26, 2005
Decision date
January 17, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MAB – Marker, Cardiopulmonary Bypass (Vein Marker)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3450
Specialty
Cardiovascular

Other 510(k)s with product code MAB

510(k)DeviceApplicantDecision
K001915Graft Marker RingMAB · Traditional T. Korossurgical Instruments Corp.04/27/2001SE
K894268C.A.B. RingMAB · Traditional Medi-Sharp, Inc.08/17/1989SE

Questions and answers

When was Suturing Washer cleared by the FDA?

Suturing Washer (K052642) received a 510(k) decision of Substantially Equivalent on January 17, 2006, 113 days after the submission was received.

What is the product code of K052642?

The FDA product code is MAB – Marker, Cardiopulmonary Bypass (Vein Marker), a Class II (moderate risk) device regulated under 21 CFR 870.3450.