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FDA 510(k)

NEGATIVE PRESSURE ARTERIAL BLOOD LINE

K-Number: K830326 · 1983-02-28

ApplicantErika, Inc.
Decision Date1983-02-28
Product CodeKDC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEGATIVE PRESSURE ARTERIAL BLOOD LINE is the device name listed in this FDA 510(k) record. The listed applicant is Erika, Inc.. It received FDA 510(k) clearance on 1983-02-28 under 510(k) number K830326. The device is classified under product code KDC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEGATIVE PRESSURE ARTERIAL BLOOD LINE?

NEGATIVE PRESSURE ARTERIAL BLOOD LINE is a medical device that received FDA 510(k) clearance on 1983-02-28. The listed applicant is Erika, Inc.. The 510(k) number is K830326.

When did NEGATIVE PRESSURE ARTERIAL BLOOD LINE receive FDA 510(k) clearance?

NEGATIVE PRESSURE ARTERIAL BLOOD LINE received FDA 510(k) clearance on 1983-02-28, under 510(k) number K830326.

Who is the listed applicant for NEGATIVE PRESSURE ARTERIAL BLOOD LINE?

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

What is the FDA product code for NEGATIVE PRESSURE ARTERIAL BLOOD LINE?

The FDA product code for NEGATIVE PRESSURE ARTERIAL BLOOD LINE is KDC.

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Other records listing Erika, 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.

K853134NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8K852310NATURALYTE BICARBONATE CONCENTRATE-DRY PACKK852309ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1LK850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-K850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID

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Related Devices (Code: KDC)

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.

K943229DISPOSABLE SURGICAL SCISSORS AND FORCEPSY.M.K. International Co., Ltd.K936226SURGIMED BREAST LOCALIZATION NEEDLE WIRE SETMeadox Medicals, Div. Boston Scientific Corp.K920153THERMUFF BAGTechstylesK920263MANUAL SURGICAL INSTRUMENTSPhoenix Instruments Div.K915064DISPOSABLE CAUTERY ABRASIVE PADAmerican Medical Mfg., Inc.K914960INSTRUMENT ORGANIZERO.R. Concepts, 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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