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FDA 510(k)

LARGE LUMEN Y ADAPTER W/ROTATING DEVICE

K-Number: K880831 · 1988-05-10

ApplicantInterventional Medical, Inc.
Decision Date1988-05-10
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LARGE LUMEN Y ADAPTER W/ROTATING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Medical, Inc.. It received FDA 510(k) clearance on 1988-05-10 under 510(k) number K880831. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LARGE LUMEN Y ADAPTER W/ROTATING DEVICE?

LARGE LUMEN Y ADAPTER W/ROTATING DEVICE is a medical device that received FDA 510(k) clearance on 1988-05-10. The listed applicant is Interventional Medical, Inc.. The 510(k) number is K880831.

When did LARGE LUMEN Y ADAPTER W/ROTATING DEVICE receive FDA 510(k) clearance?

LARGE LUMEN Y ADAPTER W/ROTATING DEVICE received FDA 510(k) clearance on 1988-05-10, under 510(k) number K880831.

Who is the listed applicant for LARGE LUMEN Y ADAPTER W/ROTATING DEVICE?

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

What is the FDA product code for LARGE LUMEN Y ADAPTER W/ROTATING DEVICE?

The FDA product code for LARGE LUMEN Y ADAPTER W/ROTATING DEVICE is DTL.

Related Clinical Trials

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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Other records listing Interventional Medical, 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.

K841071PRESSURE MANOMETERK830609INFLATION DEVICEK822243GUIDING CATHETER

Related Devices (Code: DTL)

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.

K131124COLIGNJilin Coronado Medical , Ltd.K123448AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVEMedtronic, Inc.K122811CONNECTOR COMPONENTS WITH BALANCE BIOSURFACEMedtronic, Inc.K122301GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVEVascular Solutions Zerusa , Ltd.K120069MEDLINE STOPCOCK AND MANIFOLDMedline Industries, Inc.K113148E-PASSSynexmed(Shenzhen)Company Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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