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FDA 510(k)

COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK

K-Number: K881330 · 1988-06-10

ApplicantCobe Laboratories, Inc.
Decision Date1988-06-10
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK 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 1988-06-10 under 510(k) number K881330. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK?

COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK is a medical device that received FDA 510(k) clearance on 1988-06-10. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K881330.

When did COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK receive FDA 510(k) clearance?

COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK received FDA 510(k) clearance on 1988-06-10, under 510(k) number K881330.

Who is the listed applicant for COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK?

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 HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK?

The FDA product code for COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK is DWF.

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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: DWF)

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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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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