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FDA 510(k)

DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE

K-Number: K863482 · 1986-10-14

ApplicantCardio Metrics, Inc.
Decision Date1986-10-14
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE 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 1986-10-14 under 510(k) number K863482. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE?

DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE is a medical device that received FDA 510(k) clearance on 1986-10-14. The listed applicant is Cardio Metrics, Inc.. The 510(k) number is K863482.

When did DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE receive FDA 510(k) clearance?

DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE received FDA 510(k) clearance on 1986-10-14, under 510(k) number K863482.

Who is the listed applicant for DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE?

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 DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE?

The FDA product code for DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE is GCY.

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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)

View all 23 devices →

Related Devices (Code: GCY)

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.

K972703REDYROB-CLOSED WOUND DRAINAGE SYSTEMB.Braun Medical, Inc.K971036ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.K963839CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.K950754MACRO SUCTION TUBE MODEL NO 10061Dlp, Inc.K936223PRESSURE IRRIGATING SYSTEMLevel 1 Technologies, Inc.

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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