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FDA 510(k)

CAPIOX RX HARDSHELL RESERVOIR

K-Number: K013526 · 2001-11-15

ApplicantTerumo Cardiovascular Systems Corp.
Decision Date2001-11-15
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPIOX RX HARDSHELL 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 2001-11-15 under 510(k) number K013526. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPIOX RX HARDSHELL RESERVOIR?

CAPIOX RX HARDSHELL RESERVOIR is a medical device that received FDA 510(k) clearance on 2001-11-15. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K013526.

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

CAPIOX RX HARDSHELL RESERVOIR received FDA 510(k) clearance on 2001-11-15, under 510(k) number K013526.

Who is the listed applicant for CAPIOX RX HARDSHELL 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 RX HARDSHELL RESERVOIR?

The FDA product code for CAPIOX RX HARDSHELL RESERVOIR is DTN.

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Other records listing Terumo Cardiovascular Systems Corp. as applicant

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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: DTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mLMedtronic Cardiac SurgeryK223361BMR 1900 PHISIOSorin Group Italia S.R.L.K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc.K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia S.R.L.

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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