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FDA 510(k)

SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015

K-Number: K770852 · 1977-07-14

ApplicantConcord Laboratories, Inc.
Decision Date1977-07-14
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015 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 1977-07-14 under 510(k) number K770852. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015?

SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015 is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Concord Laboratories, Inc.. The 510(k) number is K770852.

When did SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015 receive FDA 510(k) clearance?

SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015 received FDA 510(k) clearance on 1977-07-14, under 510(k) number K770852.

Who is the listed applicant for SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015?

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 SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015?

The FDA product code for SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015 is FMF.

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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: FMF)

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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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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