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FDA 510(k)

LARGE BORE SPLITTABLE INTRODUCER KIT

K-Number: K043438 · 2005-02-15

ApplicantThomas Medical Products, Inc.
Decision Date2005-02-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LARGE BORE SPLITTABLE INTRODUCER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Thomas Medical Products, Inc.. It received FDA 510(k) clearance on 2005-02-15 under 510(k) number K043438. 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 LARGE BORE SPLITTABLE INTRODUCER KIT?

LARGE BORE SPLITTABLE INTRODUCER KIT is a medical device that received FDA 510(k) clearance on 2005-02-15. The listed applicant is Thomas Medical Products, Inc.. The 510(k) number is K043438.

When did LARGE BORE SPLITTABLE INTRODUCER KIT receive FDA 510(k) clearance?

LARGE BORE SPLITTABLE INTRODUCER KIT received FDA 510(k) clearance on 2005-02-15, under 510(k) number K043438.

Who is the listed applicant for LARGE BORE SPLITTABLE INTRODUCER KIT?

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

What is the FDA product code for LARGE BORE SPLITTABLE INTRODUCER KIT?

The FDA product code for LARGE BORE SPLITTABLE INTRODUCER KIT is DYB.

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Other records listing Thomas Medical Products, 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.

K122431HEARTSPAN STEERABLE INTRODUCER KITK120158CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITSK101015GUIDE CATHETERS AND ACCESSORIESK083269CROSSOVERK081341REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)K072745Y-GLIDE

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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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