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FDA 510(k)

CARDIOTOMY RESERVOIR WITH FILTER

K-Number: K801360 · 1980-07-14

ApplicantTravenol Laboratories, S.A.
Decision Date1980-07-14
Product CodeDTP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTOMY RESERVOIR WITH FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801360. 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 CARDIOTOMY RESERVOIR WITH FILTER?

CARDIOTOMY RESERVOIR WITH FILTER is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K801360.

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

CARDIOTOMY RESERVOIR WITH FILTER received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801360.

Who is the listed applicant for CARDIOTOMY RESERVOIR WITH FILTER?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOTOMY RESERVOIR WITH FILTER?

The FDA product code for CARDIOTOMY RESERVOIR WITH FILTER is DTP.

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Other records listing Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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Related Devices (Code: DTP)

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.

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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