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FDA 510(k)

PORTA-FIB LPD

K-Number: K801544 · 1980-07-14

ApplicantNarco Bio-Systems
Decision Date1980-07-14
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PORTA-FIB LPD is the device name listed in this FDA 510(k) record. The listed applicant is Narco Bio-Systems. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801544. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTA-FIB LPD?

PORTA-FIB LPD is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Narco Bio-Systems. The 510(k) number is K801544.

When did PORTA-FIB LPD receive FDA 510(k) clearance?

PORTA-FIB LPD received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801544.

Who is the listed applicant for PORTA-FIB LPD?

The FDA 510(k) record lists Narco Bio-Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTA-FIB LPD?

The FDA product code for PORTA-FIB LPD is LDD.

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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 Narco Bio-Systems 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.

K853683UMS-100K833656NARCOTRACE 40 - NT40K832869MOTILITY MEASUREMENT SYS MMS-100K813502NARCO TELECARE ISOFLO PRESSURE MONITORK811376ULTRASONIC QFM SYSTEM 1000K810431NARCO TLECARE MINIATURE PRESSURE DOME

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Related Devices (Code: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, 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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