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FDA 510(k)

PERCUTANEOUS ANGIOGRAPHIC NEEDLES

K-Number: K845037 · 1985-06-21

ApplicantMallinckrodt Critical Care
Decision Date1985-06-21
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS ANGIOGRAPHIC NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1985-06-21 under 510(k) number K845037. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERCUTANEOUS ANGIOGRAPHIC NEEDLES?

PERCUTANEOUS ANGIOGRAPHIC NEEDLES is a medical device that received FDA 510(k) clearance on 1985-06-21. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K845037.

When did PERCUTANEOUS ANGIOGRAPHIC NEEDLES receive FDA 510(k) clearance?

PERCUTANEOUS ANGIOGRAPHIC NEEDLES received FDA 510(k) clearance on 1985-06-21, under 510(k) number K845037.

Who is the listed applicant for PERCUTANEOUS ANGIOGRAPHIC NEEDLES?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERCUTANEOUS ANGIOGRAPHIC NEEDLES?

The FDA product code for PERCUTANEOUS ANGIOGRAPHIC NEEDLES is DYB.

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Other records listing Mallinckrodt Critical Care as applicant

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Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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