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FDA 510(k)

CAPIOX CR-CARDIOTOMY RESERVOIR

K-Number: K821538 · 1982-08-06

ApplicantTerumo Medical Corp.
Decision Date1982-08-06
Product CodeDTP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPIOX CR-CARDIOTOMY RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1982-08-06 under 510(k) number K821538. The device is classified under product code DTP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPIOX CR-CARDIOTOMY RESERVOIR?

CAPIOX CR-CARDIOTOMY RESERVOIR is a medical device that received FDA 510(k) clearance on 1982-08-06. The listed applicant is Terumo Medical Corp.. The 510(k) number is K821538.

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

CAPIOX CR-CARDIOTOMY RESERVOIR received FDA 510(k) clearance on 1982-08-06, under 510(k) number K821538.

Who is the listed applicant for CAPIOX CR-CARDIOTOMY RESERVOIR?

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

What is the FDA product code for CAPIOX CR-CARDIOTOMY RESERVOIR?

The FDA product code for CAPIOX CR-CARDIOTOMY RESERVOIR is DTP.

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Other records listing Terumo Medical Corp. as applicant

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.

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Related Devices (Code: DTP)

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K101186AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAGMedtronic Perfusion SystemsK082412VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160Mapquet Cardiopulmonary AGK004046COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIRCobe Cardiovascular, Inc.K002591COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIRCobe Cardiovascular, Inc.K990514MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VRC.R. Bard, Inc.K984322DIDECO D920, LILLIPUT 1 TWIN RESERVOIRDideco S.P.A.

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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