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FDA 510(k)

MEADOX SURGIMED A/S CATHETER SHEATH SYS

K-Number: K843798 · 1984-12-27

ApplicantMeadox Surgimed, Inc.
Decision Date1984-12-27
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEADOX SURGIMED A/S CATHETER SHEATH SYS is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Surgimed, Inc.. It received FDA 510(k) clearance on 1984-12-27 under 510(k) number K843798. 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 MEADOX SURGIMED A/S CATHETER SHEATH SYS?

MEADOX SURGIMED A/S CATHETER SHEATH SYS is a medical device that received FDA 510(k) clearance on 1984-12-27. The listed applicant is Meadox Surgimed, Inc.. The 510(k) number is K843798.

When did MEADOX SURGIMED A/S CATHETER SHEATH SYS receive FDA 510(k) clearance?

MEADOX SURGIMED A/S CATHETER SHEATH SYS received FDA 510(k) clearance on 1984-12-27, under 510(k) number K843798.

Who is the listed applicant for MEADOX SURGIMED A/S CATHETER SHEATH SYS?

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

What is the FDA product code for MEADOX SURGIMED A/S CATHETER SHEATH SYS?

The FDA product code for MEADOX SURGIMED A/S CATHETER SHEATH SYS is DYB.

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Other records listing Meadox Surgimed, Inc. as applicant

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K944143MS CLASSIQUE BALLOON CATHETERK945061NOPROFILE OLBERT CATHETER SYSTEMK942382MS AMPLATZ EXTRA STIFF GUIDE WIREK930201ACECUT SUTOMATIC BIOPSY SYSTEMK911635MEADOX(R) SURGIMED(R) BIOPSY GUN IIK905181NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY

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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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