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FDA 510(k)

COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER

K-Number: K902437 · 1990-12-17

ApplicantCobe Laboratories, Inc.
Decision Date1990-12-17
Product CodeDTP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1990-12-17 under 510(k) number K902437. 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 COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER?

COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER is a medical device that received FDA 510(k) clearance on 1990-12-17. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K902437.

When did COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER receive FDA 510(k) clearance?

COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER received FDA 510(k) clearance on 1990-12-17, under 510(k) number K902437.

Who is the listed applicant for COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER?

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

What is the FDA product code for COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER?

The FDA product code for COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER is DTP.

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Other records listing Cobe Laboratories, Inc. 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.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KIT

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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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