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FDA 510(k)

CATHETER, MULTIPLE LUMEN

K-Number: K820446 · 1982-03-11

ApplicantDlp, Inc.
Decision Date1982-03-11
Product CodeGBP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CATHETER, MULTIPLE LUMEN is the device name listed in this FDA 510(k) record. The listed applicant is Dlp, Inc.. It received FDA 510(k) clearance on 1982-03-11 under 510(k) number K820446. The device is classified under product code GBP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, MULTIPLE LUMEN?

CATHETER, MULTIPLE LUMEN is a medical device that received FDA 510(k) clearance on 1982-03-11. The listed applicant is Dlp, Inc.. The 510(k) number is K820446.

When did CATHETER, MULTIPLE LUMEN receive FDA 510(k) clearance?

CATHETER, MULTIPLE LUMEN received FDA 510(k) clearance on 1982-03-11, under 510(k) number K820446.

Who is the listed applicant for CATHETER, MULTIPLE LUMEN?

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

What is the FDA product code for CATHETER, MULTIPLE LUMEN?

The FDA product code for CATHETER, MULTIPLE LUMEN is GBP.

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Other records listing Dlp, 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.

K973485CLEARVIEW BLOWER/MISTERK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)K953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLETK950754MACRO SUCTION TUBE MODEL NO 10061K934215CONTAIN-ORK915268CATHETER TWO STAGE VENOUS RETURN

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Related Devices (Code: GBP)

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.

K844889MENSINK-GOOSEN CATHETERGoosen Enterprises, Inc.K821220MULTILUMEN INTRAVENOUS INFUSION CATHETERClincal Instruments Corp.

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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