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FDA 510(k)

CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER

K-Number: K131332 · 2013-07-19

ApplicantCardiosolutions, Inc.
Decision Date2013-07-19
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Cardiosolutions, Inc.. It received FDA 510(k) clearance on 2013-07-19 under 510(k) number K131332. 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 CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER?

CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER is a medical device that received FDA 510(k) clearance on 2013-07-19. The listed applicant is Cardiosolutions, Inc.. The 510(k) number is K131332.

When did CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER receive FDA 510(k) clearance?

CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER received FDA 510(k) clearance on 2013-07-19, under 510(k) number K131332.

Who is the listed applicant for CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER?

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

What is the FDA product code for CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER?

The FDA product code for CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER is DYB.

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Other records listing Cardiosolutions, 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.

K094048PERCUPRO MESSENGER BALLOON CATHETERK094062PERCU-PRO GUIDEWIRE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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