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FDA 510(k)

ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.

K-Number: K870826 · 1987-03-23

ApplicantShiley, Inc.
Decision Date1987-03-23
Product CodeDQR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN. is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1987-03-23 under 510(k) number K870826. The device is classified under product code DQR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.?

ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN. is a medical device that received FDA 510(k) clearance on 1987-03-23. The listed applicant is Shiley, Inc.. The 510(k) number is K870826.

When did ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN. receive FDA 510(k) clearance?

ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN. received FDA 510(k) clearance on 1987-03-23, under 510(k) number K870826.

Who is the listed applicant for ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.?

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

What is the FDA product code for ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.?

The FDA product code for ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN. is DQR.

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Other records listing Shiley, 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.

K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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Related Devices (Code: DQR)

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.

K131446INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLESIntegra LifeSciences CorporationK07355918 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA IIEdwards Lifesciences Research MedicalK051655ANGIODYNAMICS, INC., MICRO ACCESS KITSAngioDynamics, Inc.K030398CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221Cardiacassist, Inc.K960098RMI INTERNAL MAMMARY ARTERY CANNULAResearch Medical, Inc.K902674DATASCOPE ARTERIAL CANNULA W/ACCESS PORTDatascope Corp.

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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