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FDA 510(k)

HEARTSPAN STEERABLE INTRODUCER KIT

K-Number: K122431 · 2013-01-29

ApplicantThomas Medical Products, Inc.
Decision Date2013-01-29
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTSPAN STEERABLE 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 2013-01-29 under 510(k) number K122431. 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 HEARTSPAN STEERABLE INTRODUCER KIT?

HEARTSPAN STEERABLE INTRODUCER KIT is a medical device that received FDA 510(k) clearance on 2013-01-29. The listed applicant is Thomas Medical Products, Inc.. The 510(k) number is K122431.

When did HEARTSPAN STEERABLE INTRODUCER KIT receive FDA 510(k) clearance?

HEARTSPAN STEERABLE INTRODUCER KIT received FDA 510(k) clearance on 2013-01-29, under 510(k) number K122431.

Who is the listed applicant for HEARTSPAN STEERABLE 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 HEARTSPAN STEERABLE INTRODUCER KIT?

The FDA product code for HEARTSPAN STEERABLE 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.

K120158CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITSK101015GUIDE CATHETERS AND ACCESSORIESK083269CROSSOVERK081341REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)K072745Y-GLIDEK043438LARGE BORE SPLITTABLE INTRODUCER KIT

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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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