Sensilase Pad-Iq

FDA 510(k) K110438 · Vasamed, Inc.

Substantially Equivalent

510(k) numberK110438

Submission

Device name
Sensilase Pad-Iq
Applicant
Vasamed, Inc.
Stoughton, WI, US
Received
February 15, 2011
Decision date
May 4, 2011
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPW – Flowmeter, Blood, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2100
Specialty
Cardiovascular

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Questions and answers

When was Sensilase Pad-Iq cleared by the FDA?

Sensilase Pad-Iq (K110438) received a 510(k) decision of Substantially Equivalent on May 4, 2011, 78 days after the submission was received.

What is the product code of K110438?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.