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FDA 510(k)

TRANSLUMINAL ENDARTERECTOMY DEVICE

K-Number: K884154 · 1988-12-27

ApplicantThomas J. Fogarty, M.D.
Decision Date1988-12-27
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRANSLUMINAL ENDARTERECTOMY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Thomas J. Fogarty, M.D.. It received FDA 510(k) clearance on 1988-12-27 under 510(k) number K884154. The device is classified under product code LIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSLUMINAL ENDARTERECTOMY DEVICE?

TRANSLUMINAL ENDARTERECTOMY DEVICE is a medical device that received FDA 510(k) clearance on 1988-12-27. The listed applicant is Thomas J. Fogarty, M.D.. The 510(k) number is K884154.

When did TRANSLUMINAL ENDARTERECTOMY DEVICE receive FDA 510(k) clearance?

TRANSLUMINAL ENDARTERECTOMY DEVICE received FDA 510(k) clearance on 1988-12-27, under 510(k) number K884154.

Who is the listed applicant for TRANSLUMINAL ENDARTERECTOMY DEVICE?

The FDA 510(k) record lists Thomas J. Fogarty, M.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSLUMINAL ENDARTERECTOMY DEVICE?

The FDA product code for TRANSLUMINAL ENDARTERECTOMY DEVICE is LIF.

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 Thomas J. Fogarty, M.D. 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.

K902453OSCILLOMETRIC PULSE DETECTION DEVICEK831809FOGARTY OCCLUDER PADK841310GASTROINTESTINAL DILATORK834451COAXIAL BALLOON GASTROESOPHAGEAL DILAK831384COAXIAL BALLOON URETHRAL DILATOR

Related Devices (Code: LIF)

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.

K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux TechnologiesK043126ASSIST HEADER CLEANERAlcavis International, Inc.K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach CompanyK033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLCK013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International Incorporated

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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