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FDA 510(k)

FAST-CATH TRANSSEPTAL CATHETER INTRODUCER

K-Number: K964518 · 1997-05-14

ApplicantDaig Corp.
Decision Date1997-05-14
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FAST-CATH TRANSSEPTAL CATHETER 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 1997-05-14 under 510(k) number K964518. 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 TRANSSEPTAL CATHETER INTRODUCER?

FAST-CATH TRANSSEPTAL CATHETER INTRODUCER is a medical device that received FDA 510(k) clearance on 1997-05-14. The listed applicant is Daig Corp.. The 510(k) number is K964518.

When did FAST-CATH TRANSSEPTAL CATHETER INTRODUCER receive FDA 510(k) clearance?

FAST-CATH TRANSSEPTAL CATHETER INTRODUCER received FDA 510(k) clearance on 1997-05-14, under 510(k) number K964518.

Who is the listed applicant for FAST-CATH TRANSSEPTAL CATHETER 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 TRANSSEPTAL CATHETER INTRODUCER?

The FDA product code for FAST-CATH TRANSSEPTAL CATHETER 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.

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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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