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FDA 510(k)

ANGEION HEMOSTASIS VALVE INTRODUCER

K-Number: K894446 · 1989-11-30

ApplicantAngeion Corp.
Decision Date1989-11-30
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGEION HEMOSTASIS VALVE INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Angeion Corp.. It received FDA 510(k) clearance on 1989-11-30 under 510(k) number K894446. 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 ANGEION HEMOSTASIS VALVE INTRODUCER?

ANGEION HEMOSTASIS VALVE INTRODUCER is a medical device that received FDA 510(k) clearance on 1989-11-30. The listed applicant is Angeion Corp.. The 510(k) number is K894446.

When did ANGEION HEMOSTASIS VALVE INTRODUCER receive FDA 510(k) clearance?

ANGEION HEMOSTASIS VALVE INTRODUCER received FDA 510(k) clearance on 1989-11-30, under 510(k) number K894446.

Who is the listed applicant for ANGEION HEMOSTASIS VALVE INTRODUCER?

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

What is the FDA product code for ANGEION HEMOSTASIS VALVE INTRODUCER?

The FDA product code for ANGEION HEMOSTASIS VALVE INTRODUCER is DYB.

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Other records listing Angeion Corp. 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.

K921757ANGEION IGITAL ANGEFLATORK925533ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SETK915719ANGEION ENDOSCOPIC VALVE SEALK902377ANGEFLATOR(TM)K895580Y-ADAPTER W/THOUY BORSTK871153CATHETER INTRODUCER

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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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