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FDA 510(k)

ACCESS PERCUTANEOUS INTRODUCER SET

K-Number: K822834 · 1982-11-01

ApplicantAccess Devices, Inc.
Decision Date1982-11-01
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCESS PERCUTANEOUS INTRODUCER SET is the device name listed in this FDA 510(k) record. The listed applicant is Access Devices, Inc.. It received FDA 510(k) clearance on 1982-11-01 under 510(k) number K822834. 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 ACCESS PERCUTANEOUS INTRODUCER SET?

ACCESS PERCUTANEOUS INTRODUCER SET is a medical device that received FDA 510(k) clearance on 1982-11-01. The listed applicant is Access Devices, Inc.. The 510(k) number is K822834.

When did ACCESS PERCUTANEOUS INTRODUCER SET receive FDA 510(k) clearance?

ACCESS PERCUTANEOUS INTRODUCER SET received FDA 510(k) clearance on 1982-11-01, under 510(k) number K822834.

Who is the listed applicant for ACCESS PERCUTANEOUS INTRODUCER SET?

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

What is the FDA product code for ACCESS PERCUTANEOUS INTRODUCER SET?

The FDA product code for ACCESS PERCUTANEOUS INTRODUCER SET is DYB.

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Other records listing Access Devices, 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.

K823758CENTRAL VEIN CATHERIZATION KITK823017INTRAVENOUS CATHETER PLACEMENT UNIT &

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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