Statlock Securement Devices

FDA 510(k) K942931 · Venetec, Inc.

Substantially Equivalent

510(k) numberK942931

Submission

Device name
Statlock Securement Devices
Applicant
Venetec, Inc.
Arvada, CO, US
Received
June 22, 1994
Decision date
March 28, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FPA – Set, Administration, Intravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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More from B.Braun Medical, Inc.

510(k)DeviceDecision
K943038Statlock-IpiduralFPA · Traditional 04/10/1995SE
K943147Statlock CVKMK · Traditional 09/29/1994SE
K902109Statlock IV Connector and Anchor SetFPA · Traditional 10/19/1990SE

Questions and answers

When was Statlock Securement Devices cleared by the FDA?

Statlock Securement Devices (K942931) received a 510(k) decision of Substantially Equivalent on March 28, 1995, 279 days after the submission was received.

What is the product code of K942931?

The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.