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FDA 510(k)

A.S.A.P.

K-Number: K841318 · 1984-07-18

ApplicantTrimedyne, Inc.
Decision Date1984-07-18
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

A.S.A.P. is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1984-07-18 under 510(k) number K841318. The device is classified under product code LDR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A.S.A.P.?

A.S.A.P. is a medical device that received FDA 510(k) clearance on 1984-07-18. The listed applicant is Trimedyne, Inc.. The 510(k) number is K841318.

When did A.S.A.P. receive FDA 510(k) clearance?

A.S.A.P. received FDA 510(k) clearance on 1984-07-18, under 510(k) number K841318.

Who is the listed applicant for A.S.A.P.?

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

What is the FDA product code for A.S.A.P.?

The FDA product code for A.S.A.P. is LDR.

Other records listing Trimedyne, 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.

K053457VAPORMAX IIK050412VAPORMAXK043012OMNIPULSE MINI, MODEL 2120K041660TRIMEDYNE HOLMIUM LASER SYSTEMSK022655TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATHK013974RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A

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Related Devices (Code: LDR)

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.

K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development CorporationK232316DEKA Infusion System, DEKA Administration SetDeka Research and DevelopmentK153760Volumetric Infusion ControllerDEKA Research & DevelopmentK963136PACER MODEL 100 INFUSION CONTROLLERHealth Watch, Inc.K971826ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500Alexander Mfg. Co.K971865ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3PAlexander Mfg. Co.

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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