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FDA 510(k)

SPLITTABLE SHEATH INTRODUCER KIT

K-Number: K004025 · 2001-07-19

ApplicantThomas Medical Products, Inc.
Decision Date2001-07-19
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPLITTABLE SHEATH 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 2001-07-19 under 510(k) number K004025. 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 SPLITTABLE SHEATH INTRODUCER KIT?

SPLITTABLE SHEATH INTRODUCER KIT is a medical device that received FDA 510(k) clearance on 2001-07-19. The listed applicant is Thomas Medical Products, Inc.. The 510(k) number is K004025.

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

SPLITTABLE SHEATH INTRODUCER KIT received FDA 510(k) clearance on 2001-07-19, under 510(k) number K004025.

Who is the listed applicant for SPLITTABLE SHEATH 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 SPLITTABLE SHEATH INTRODUCER KIT?

The FDA product code for SPLITTABLE SHEATH 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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