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FDA 510(k)

MALE-MALE LUER LOCK CONNECTOR W/ROTA

K-Number: K840797 · 1984-04-24

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1984-04-24
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MALE-MALE LUER LOCK CONNECTOR W/ROTA is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1984-04-24 under 510(k) number K840797. 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 MALE-MALE LUER LOCK CONNECTOR W/ROTA?

MALE-MALE LUER LOCK CONNECTOR W/ROTA is a medical device that received FDA 510(k) clearance on 1984-04-24. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K840797.

When did MALE-MALE LUER LOCK CONNECTOR W/ROTA receive FDA 510(k) clearance?

MALE-MALE LUER LOCK CONNECTOR W/ROTA received FDA 510(k) clearance on 1984-04-24, under 510(k) number K840797.

Who is the listed applicant for MALE-MALE LUER LOCK CONNECTOR W/ROTA?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MALE-MALE LUER LOCK CONNECTOR W/ROTA?

The FDA product code for MALE-MALE LUER LOCK CONNECTOR W/ROTA is DTL.

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Other records listing American Pharmaseal Div. Ahsc as applicant

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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

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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