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FDA 510(k)

MEDIASTINAL AUTOTRANSFUSION SYSTEM

K-Number: K860775 · 1986-05-28

ApplicantCardio Metrics, Inc.
Decision Date1986-05-28
Product CodeDTP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDIASTINAL AUTOTRANSFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Metrics, Inc.. It received FDA 510(k) clearance on 1986-05-28 under 510(k) number K860775. 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 MEDIASTINAL AUTOTRANSFUSION SYSTEM?

MEDIASTINAL AUTOTRANSFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1986-05-28. The listed applicant is Cardio Metrics, Inc.. The 510(k) number is K860775.

When did MEDIASTINAL AUTOTRANSFUSION SYSTEM receive FDA 510(k) clearance?

MEDIASTINAL AUTOTRANSFUSION SYSTEM received FDA 510(k) clearance on 1986-05-28, under 510(k) number K860775.

Who is the listed applicant for MEDIASTINAL AUTOTRANSFUSION SYSTEM?

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

What is the FDA product code for MEDIASTINAL AUTOTRANSFUSION SYSTEM?

The FDA product code for MEDIASTINAL AUTOTRANSFUSION SYSTEM is DTP.

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Other records listing Cardio Metrics, 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.

K972762CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRESK965140CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEMK951567CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIREK961777ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404K955551CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404K954913CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)

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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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