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FDA 510(k)

CATHETER INTRODUCER

K-Number: K920528 · 1992-08-12

ApplicantBoston Scientific Corp
Decision Date1992-08-12
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1992-08-12 under 510(k) number K920528. 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?

CATHETER INTRODUCER is a medical device that received FDA 510(k) clearance on 1992-08-12. The listed applicant is Boston Scientific Corp. The 510(k) number is K920528.

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

CATHETER INTRODUCER received FDA 510(k) clearance on 1992-08-12, under 510(k) number K920528.

Who is the listed applicant for CATHETER INTRODUCER?

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

What is the FDA product code for CATHETER INTRODUCER?

The FDA product code for CATHETER INTRODUCER is DYB.

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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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