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FDA 510(k)

CATHETER,PERCUTANEOUS INTRODUC. & SHEATH

K-Number: K770561 · 1977-04-26

ApplicantUsci, Div. C.R. Bard, Inc.
Decision Date1977-04-26
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER,PERCUTANEOUS INTRODUC. & SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Usci, Div. C.R. Bard, Inc.. It received FDA 510(k) clearance on 1977-04-26 under 510(k) number K770561. 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,PERCUTANEOUS INTRODUC. & SHEATH?

CATHETER,PERCUTANEOUS INTRODUC. & SHEATH is a medical device that received FDA 510(k) clearance on 1977-04-26. The listed applicant is Usci, Div. C.R. Bard, Inc.. The 510(k) number is K770561.

When did CATHETER,PERCUTANEOUS INTRODUC. & SHEATH receive FDA 510(k) clearance?

CATHETER,PERCUTANEOUS INTRODUC. & SHEATH received FDA 510(k) clearance on 1977-04-26, under 510(k) number K770561.

Who is the listed applicant for CATHETER,PERCUTANEOUS INTRODUC. & SHEATH?

The FDA 510(k) record lists Usci, Div. C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATHETER,PERCUTANEOUS INTRODUC. & SHEATH?

The FDA product code for CATHETER,PERCUTANEOUS INTRODUC. & SHEATH is DYB.

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Other records listing Usci, Div. C.R. Bard, 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.

K940092USCI INPUT INTRODUCER SETK884209USCI DORROS INFUSION/PROBING CATHETERK771823CATHETER, CARDIOVASCULARK772021TRC STAINLESS STEEL SAFETY SPRING GUIDESK771982888 ARTERIAL/VENOUS CATHETER INTRODUCERK770835PATCH FABRIC

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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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