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FDA 510(k)

PREFILLED PULSATOR SYRINGE

K-Number: K840986 · 1984-04-05

ApplicantConcord Laboratories, Inc.
Decision Date1984-04-05
Product CodeCBT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PREFILLED PULSATOR SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Concord Laboratories, Inc.. It received FDA 510(k) clearance on 1984-04-05 under 510(k) number K840986. The device is classified under product code CBT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREFILLED PULSATOR SYRINGE?

PREFILLED PULSATOR SYRINGE is a medical device that received FDA 510(k) clearance on 1984-04-05. The listed applicant is Concord Laboratories, Inc.. The 510(k) number is K840986.

When did PREFILLED PULSATOR SYRINGE receive FDA 510(k) clearance?

PREFILLED PULSATOR SYRINGE received FDA 510(k) clearance on 1984-04-05, under 510(k) number K840986.

Who is the listed applicant for PREFILLED PULSATOR SYRINGE?

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

What is the FDA product code for PREFILLED PULSATOR SYRINGE?

The FDA product code for PREFILLED PULSATOR SYRINGE is CBT.

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Other records listing Concord Laboratories, 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.

K883840DRI-VENT ARTERIAL BLOOD SAMPLING KITK871825MECONIUM SUCTION CATHETERK864535TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110K862039CONCORD CARE TRAYK854601SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATHK854327SUBCUTANEOUS TUNNELING NEEDLES & HANDLES

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Related Devices (Code: CBT)

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.

K071269HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K070340SECURE ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K955663ABC IN-LINE BLOOD SAMPLING KITUtah Medical Products, Inc.K954015ABG POINT LOK NEEDLE PROTECTION DEVICEDevon Industries, Inc.K954035ACTI-FLEX ARTERIAL EXTENSION SETR-Group Intl.K950098NEEDLE SAFETY COVERHammer-Plane, 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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