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)

PERCUTANEOUS INTRODUCER KIT

K-Number: K123974 · 2013-02-21

ApplicantTeleflex, Inc.
Decision Date2013-02-21
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS INTRODUCER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex, Inc.. It received FDA 510(k) clearance on 2013-02-21 under 510(k) number K123974. 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 PERCUTANEOUS INTRODUCER KIT?

PERCUTANEOUS INTRODUCER KIT is a medical device that received FDA 510(k) clearance on 2013-02-21. The listed applicant is Teleflex, Inc.. The 510(k) number is K123974.

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

PERCUTANEOUS INTRODUCER KIT received FDA 510(k) clearance on 2013-02-21, under 510(k) number K123974.

Who is the listed applicant for PERCUTANEOUS INTRODUCER KIT?

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

What is the FDA product code for PERCUTANEOUS INTRODUCER KIT?

The FDA product code for PERCUTANEOUS INTRODUCER KIT 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 Teleflex, 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.

K153652ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetK121403CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SETK103658FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTERK861951MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETERK860307PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET

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.

↑