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FDA 510(k)

COBE SINGLE-NEEDLE CONTROLLER #18-756

K-Number: K820173 · 1982-03-23

ApplicantCobe Laboratories, Inc.
Decision Date1982-03-23
Product CodeFIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COBE SINGLE-NEEDLE CONTROLLER #18-756 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 1982-03-23 under 510(k) number K820173. The device is classified under product code FIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE SINGLE-NEEDLE CONTROLLER #18-756?

COBE SINGLE-NEEDLE CONTROLLER #18-756 is a medical device that received FDA 510(k) clearance on 1982-03-23. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K820173.

When did COBE SINGLE-NEEDLE CONTROLLER #18-756 receive FDA 510(k) clearance?

COBE SINGLE-NEEDLE CONTROLLER #18-756 received FDA 510(k) clearance on 1982-03-23, under 510(k) number K820173.

Who is the listed applicant for COBE SINGLE-NEEDLE CONTROLLER #18-756?

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 SINGLE-NEEDLE CONTROLLER #18-756?

The FDA product code for COBE SINGLE-NEEDLE CONTROLLER #18-756 is FIF.

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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: FIF)

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.

K8732798810 PUMP-PUMP SINGLE NEEDLE DEVICECd Medical, Inc.K802230BELLCO SINGLE NEEDLE DOUBLE HEAD PUMPCardio Med Supplies, Inc.K801967MEDCOMP FEMORAL VEIN CATHETERMedical Components, Inc.K792174MODEL DM 353 & DM-353-L SINGLE NEEDLEExtracorporeal Medical Specialities, Inc.K772147GW 35 GUIDE WIRESorensen Research

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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