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FDA 510(k)

CAPIOX CARDIOTOMY RESERVOIR

K-Number: K030505 · 2003-05-14

ApplicantTerumo Cardiovascular Systems Corp.
Decision Date2003-05-14
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPIOX CARDIOTOMY RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corp.. It received FDA 510(k) clearance on 2003-05-14 under 510(k) number K030505. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPIOX CARDIOTOMY RESERVOIR?

CAPIOX CARDIOTOMY RESERVOIR is a medical device that received FDA 510(k) clearance on 2003-05-14. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K030505.

When did CAPIOX CARDIOTOMY RESERVOIR receive FDA 510(k) clearance?

CAPIOX CARDIOTOMY RESERVOIR received FDA 510(k) clearance on 2003-05-14, under 510(k) number K030505.

Who is the listed applicant for CAPIOX CARDIOTOMY RESERVOIR?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPIOX CARDIOTOMY RESERVOIR?

The FDA product code for CAPIOX CARDIOTOMY RESERVOIR is DPW.

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K130333CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIRK130359CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHAK123039CDI BLOOD PARAMETER MONITORING SYSTEM 500K113214TLINK DATA MANAGEMENT SYSTEM (DMS)K112587ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,K092789VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM

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Related Devices (Code: DPW)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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