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FDA 510(k)

PERCUTANEOUS SHEATH INTRODUCER TRAY

K-Number: K834074 · 1984-03-19

ApplicantPackaging Technologies, Inc.
Decision Date1984-03-19
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS SHEATH INTRODUCER TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Packaging Technologies, Inc.. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K834074. 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 SHEATH INTRODUCER TRAY?

PERCUTANEOUS SHEATH INTRODUCER TRAY is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Packaging Technologies, Inc.. The 510(k) number is K834074.

When did PERCUTANEOUS SHEATH INTRODUCER TRAY receive FDA 510(k) clearance?

PERCUTANEOUS SHEATH INTRODUCER TRAY received FDA 510(k) clearance on 1984-03-19, under 510(k) number K834074.

Who is the listed applicant for PERCUTANEOUS SHEATH INTRODUCER TRAY?

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

What is the FDA product code for PERCUTANEOUS SHEATH INTRODUCER TRAY?

The FDA product code for PERCUTANEOUS SHEATH INTRODUCER TRAY is DYB.

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Other records listing Packaging Technologies, 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.

K881756STERILE SURGEONS GLOVESK863326BONE MARROW TRAYK861041ENHANCEK850544SHAVE PREP TRAYK850438RENAL BIOPSY TRAYK844613GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR

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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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