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FDA 510(k)

DISPOSABLE INTRODUCER SHEATH

K-Number: K910079 · 1991-02-27

ApplicantApplied Vascular Devices, Inc.
Decision Date1991-02-27
Product CodeKDC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Applied Vascular Devices, Inc.. It received FDA 510(k) clearance on 1991-02-27 under 510(k) number K910079. The device is classified under product code KDC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE INTRODUCER SHEATH?

DISPOSABLE INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 1991-02-27. The listed applicant is Applied Vascular Devices, Inc.. The 510(k) number is K910079.

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

DISPOSABLE INTRODUCER SHEATH received FDA 510(k) clearance on 1991-02-27, under 510(k) number K910079.

Who is the listed applicant for DISPOSABLE INTRODUCER SHEATH?

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

What is the FDA product code for DISPOSABLE INTRODUCER SHEATH?

The FDA product code for DISPOSABLE INTRODUCER SHEATH is KDC.

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Other records listing Applied Vascular 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.

K911730SURGICAL OBTURATOR WITH SEALK911589DISPOSABLE SURGICAL TROCAR WITH SEALK910339AVD INTIMAX OCCLUSION CATHETERK910372INTIMAX THROMBECTOMY CATHETERK911181INTIMAX(TM) IRRIGATION CATHETERK910493AVD INTIMAX CHOLANGIOGRAPHY CATHETER

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Related Devices (Code: KDC)

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.

K943229DISPOSABLE SURGICAL SCISSORS AND FORCEPSY.M.K. International Co., Ltd.K936226SURGIMED BREAST LOCALIZATION NEEDLE WIRE SETMeadox Medicals, Div. Boston Scientific Corp.K920153THERMUFF BAGTechstylesK920263MANUAL SURGICAL INSTRUMENTSPhoenix Instruments Div.K915064DISPOSABLE CAUTERY ABRASIVE PADAmerican Medical Mfg., Inc.K914960INSTRUMENT ORGANIZERO.R. Concepts, Inc.

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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