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FDA 510(k)

CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015

K-Number: K880860 · 1988-05-26

ApplicantDlp, Inc.
Decision Date1988-05-26
Product CodeDQT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 is the device name listed in this FDA 510(k) record. The listed applicant is Dlp, Inc.. It received FDA 510(k) clearance on 1988-05-26 under 510(k) number K880860. The device is classified under product code DQT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015?

CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 is a medical device that received FDA 510(k) clearance on 1988-05-26. The listed applicant is Dlp, Inc.. The 510(k) number is K880860.

When did CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 receive FDA 510(k) clearance?

CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 received FDA 510(k) clearance on 1988-05-26, under 510(k) number K880860.

Who is the listed applicant for CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015?

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 CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015?

The FDA product code for CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 is DQT.

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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: DQT)

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.

K983927GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORTArterial Vascular Engineering, Inc.K945963THE OMNIGUIDE GUIDING CATHETER WITH BALLOONMicro Interventional Systems, Inc.K910916CATHLAB SILICONE OCCLUSION BALLOON CATHETERCathlab Corp.K910339AVD INTIMAX OCCLUSION CATHETERApplied Vascular Devices, Inc.K880231MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETERIdeas For Medicine, Inc.K872090THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KITIdeas For Medicine, 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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