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FDA 510(k)

FAST-CATH INTRA-CARDIAC INTRODUCER

K-Number: K982187 · 1998-09-16

ApplicantDaig Corp.
Decision Date1998-09-16
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FAST-CATH INTRA-CARDIAC INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Daig Corp.. It received FDA 510(k) clearance on 1998-09-16 under 510(k) number K982187. 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 FAST-CATH INTRA-CARDIAC INTRODUCER?

FAST-CATH INTRA-CARDIAC INTRODUCER is a medical device that received FDA 510(k) clearance on 1998-09-16. The listed applicant is Daig Corp.. The 510(k) number is K982187.

When did FAST-CATH INTRA-CARDIAC INTRODUCER receive FDA 510(k) clearance?

FAST-CATH INTRA-CARDIAC INTRODUCER received FDA 510(k) clearance on 1998-09-16, under 510(k) number K982187.

Who is the listed applicant for FAST-CATH INTRA-CARDIAC INTRODUCER?

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

What is the FDA product code for FAST-CATH INTRA-CARDIAC INTRODUCER?

The FDA product code for FAST-CATH INTRA-CARDIAC INTRODUCER is DYB.

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Other records listing Daig 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.

K000004ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509K994334ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXXK982299SPYGLASS 5 FR ANGIOGRAPHIC CATHETERK973840FAST-CATH (TM) INTRA-CARDIAC INTRODUCERK964518FAST-CATH TRANSSEPTAL CATHETER INTRODUCERK965249SPYGLASS ANGIOGRAPHIC 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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