Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS

K-Number: K120158 · 2012-08-14

ApplicantThomas Medical Products, Inc.
Decision Date2012-08-14
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS 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 2012-08-14 under 510(k) number K120158. 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 CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS?

CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS is a medical device that received FDA 510(k) clearance on 2012-08-14. The listed applicant is Thomas Medical Products, Inc.. The 510(k) number is K120158.

When did CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS receive FDA 510(k) clearance?

CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS received FDA 510(k) clearance on 2012-08-14, under 510(k) number K120158.

Who is the listed applicant for CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS?

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 CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS?

The FDA product code for CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS is DYB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 KITK101015GUIDE CATHETERS AND ACCESSORIESK083269CROSSOVERK081341REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)K072745Y-GLIDEK043438LARGE BORE SPLITTABLE INTRODUCER KIT

View all 23 devices →

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.

↑