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FDA 510(k)

CATHETER INTRODUCER SHEATH

K-Number: K890766 · 1989-09-18

ApplicantApplied Vascular Devices, Inc.
Decision Date1989-09-18
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER 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 1989-09-18 under 510(k) number K890766. 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 CATHETER INTRODUCER SHEATH?

CATHETER INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 1989-09-18. The listed applicant is Applied Vascular Devices, Inc.. The 510(k) number is K890766.

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

CATHETER INTRODUCER SHEATH received FDA 510(k) clearance on 1989-09-18, under 510(k) number K890766.

Who is the listed applicant for CATHETER 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 CATHETER INTRODUCER SHEATH?

The FDA product code for CATHETER INTRODUCER SHEATH is DYB.

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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: 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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