Capiox Cardiotomy Reservoir

FDA 510(k) K030505 · Terumo Cardiovascular Systems Corp.

Substantially Equivalent

510(k) numberK030505

Submission

Device name
Capiox Cardiotomy Reservoir
Applicant
Terumo Cardiovascular Systems Corp.
Elkton, MD, US
Received
February 19, 2003
Decision date
May 14, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 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 Capiox Cardiotomy Reservoir cleared by the FDA?

Capiox Cardiotomy Reservoir (K030505) received a 510(k) decision of Substantially Equivalent on May 14, 2003, 84 days after the submission was received.

What is the product code of K030505?

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