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FDA 510(k)

STARCLOSE INTRODUCER SET MODEL- 1002

K-Number: K060902 · 2006-07-07

ApplicantAbbott Vascular, Inc.
Decision Date2006-07-07
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STARCLOSE INTRODUCER SET MODEL- 1002 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular, Inc.. It received FDA 510(k) clearance on 2006-07-07 under 510(k) number K060902. 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 STARCLOSE INTRODUCER SET MODEL- 1002?

STARCLOSE INTRODUCER SET MODEL- 1002 is a medical device that received FDA 510(k) clearance on 2006-07-07. The listed applicant is Abbott Vascular, Inc.. The 510(k) number is K060902.

When did STARCLOSE INTRODUCER SET MODEL- 1002 receive FDA 510(k) clearance?

STARCLOSE INTRODUCER SET MODEL- 1002 received FDA 510(k) clearance on 2006-07-07, under 510(k) number K060902.

Who is the listed applicant for STARCLOSE INTRODUCER SET MODEL- 1002?

The FDA 510(k) record lists Abbott Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STARCLOSE INTRODUCER SET MODEL- 1002?

The FDA product code for STARCLOSE INTRODUCER SET MODEL- 1002 is DYB.

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Other records listing Abbott Vascular, Inc. as applicant

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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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