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FDA 510(k)

ANGEION ENDOSCOPIC VALVE SEAL

K-Number: K915719 · 1992-02-18

ApplicantAngeion Corp.
Decision Date1992-02-18
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANGEION ENDOSCOPIC VALVE SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Angeion Corp.. It received FDA 510(k) clearance on 1992-02-18 under 510(k) number K915719. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGEION ENDOSCOPIC VALVE SEAL?

ANGEION ENDOSCOPIC VALVE SEAL is a medical device that received FDA 510(k) clearance on 1992-02-18. The listed applicant is Angeion Corp.. The 510(k) number is K915719.

When did ANGEION ENDOSCOPIC VALVE SEAL receive FDA 510(k) clearance?

ANGEION ENDOSCOPIC VALVE SEAL received FDA 510(k) clearance on 1992-02-18, under 510(k) number K915719.

Who is the listed applicant for ANGEION ENDOSCOPIC VALVE SEAL?

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 ENDOSCOPIC VALVE SEAL?

The FDA product code for ANGEION ENDOSCOPIC VALVE SEAL is ODC.

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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 SETK902377ANGEFLATOR(TM)K895580Y-ADAPTER W/THOUY BORSTK894446ANGEION HEMOSTASIS VALVE INTRODUCERK871153CATHETER INTRODUCER

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Related Devices (Code: ODC)

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.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

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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