FDA 510(k)

CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING

K-Number: K002238 · 2000-08-22

ApplicantTerumo Cardiovascular Systems Corp.

Decision Date2000-08-22

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING 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 2000-08-22 under 510(k) number K002238. 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 SX HARDSHELL RESERVOIR WITH X-COATING?

CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING is a medical device that received FDA 510(k) clearance on 2000-08-22. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K002238.

When did CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING receive FDA 510(k) clearance?

CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING received FDA 510(k) clearance on 2000-08-22, under 510(k) number K002238.

Who is the listed applicant for CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING?

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 SX HARDSHELL RESERVOIR WITH X-COATING?

The FDA product code for CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING is DTN.

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Other records listing Terumo Cardiovascular Systems Corp. as applicant

K130333CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR K130359CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA K123039CDI BLOOD PARAMETER MONITORING SYSTEM 500 K113214TLINK 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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Official Source

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