Deka Tac Device

FDA 510(k) K093915 · Deka Research & Development Corp.

Substantially Equivalent

510(k) numberK093915

Submission

Device name
Deka Tac Device
Applicant
Deka Research & Development Corp.
Manchester, NH, US
Received
December 22, 2009
Decision date
August 23, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FIG – Clamp, Tubing, Blood, Automatic
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

Other 510(k)s with product code FIG

510(k)DeviceApplicantDecision
K921993Els Automatic Tubing Clamp SystemFIG · Traditional Rocky Mountain Research, Inc.01/05/1994SE
K914459Automatic Tubing ClampFIG · Traditional Rocky Mountain Research, Inc.06/24/1992SE
K770535C-Dak 3500FIG · Traditional Cordis Corp.04/15/1977SE

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Questions and answers

When was Deka Tac Device cleared by the FDA?

Deka Tac Device (K093915) received a 510(k) decision of Substantially Equivalent on August 23, 2011, 609 days after the submission was received.

What is the product code of K093915?

The FDA product code is FIG – Clamp, Tubing, Blood, Automatic, a Class II (moderate risk) device regulated under 21 CFR 876.5820.